apremilast Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| phosphodiesterase IV (PDE IV) inhibitors | 4829 | 608141-41-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action in psoriatic arthritis patients and psoriasis patients is not well defined.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 60 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| CL (Clearance) | 2.38 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.32 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 6.03 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 20, 2019 | PMDA | Celgene K.K. | |
| March 21, 2014 | FDA | CELGENE CORP | |
| Nov. 20, 2014 | EMA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diarrhoea | 20479.44 | 68.85 | 7287 | 30115 | 76277 | 2244406 |
| Nausea | 18480.88 | 68.85 | 7314 | 30088 | 104875 | 2215808 |
| Psoriasis | 17007.27 | 68.85 | 4421 | 32981 | 12587 | 2308096 |
| Headache | 13793.70 | 68.85 | 5435 | 31967 | 74744 | 2245939 |
| Drug ineffective | 5676.83 | 68.85 | 3199 | 34203 | 98425 | 2222258 |
| Product dose omission | 5482.76 | 68.85 | 2303 | 35099 | 35954 | 2284729 |
| Abdominal discomfort | 5408.29 | 68.85 | 1849 | 35553 | 15607 | 2305076 |
| Psoriatic arthropathy | 4403.40 | 68.85 | 1128 | 36274 | 2786 | 2317897 |
| Depression | 3178.01 | 68.85 | 1437 | 35965 | 26695 | 2293988 |
| Weight decreased | 2725.42 | 68.85 | 1296 | 36106 | 27075 | 2293608 |
| Vomiting | 2167.55 | 68.85 | 1542 | 35860 | 70060 | 2250623 |
| Adverse drug reaction | 2112.86 | 68.85 | 762 | 36640 | 7521 | 2313162 |
| Abdominal pain upper | 2047.55 | 68.85 | 986 | 36416 | 21114 | 2299569 |
| Rash | 1554.52 | 68.85 | 1175 | 36227 | 58383 | 2262300 |
| Therapy non-responder | 1353.91 | 68.85 | 548 | 36854 | 7556 | 2313127 |
| Migraine | 1282.98 | 68.85 | 571 | 36831 | 10082 | 2310601 |
| Insomnia | 1074.64 | 68.85 | 680 | 36722 | 25107 | 2295576 |
| Arthralgia | 1017.43 | 68.85 | 884 | 36518 | 53401 | 2267282 |
| Decreased appetite | 1006.42 | 68.85 | 681 | 36721 | 28210 | 2292473 |
| Gastric disorder | 965.91 | 68.85 | 347 | 37055 | 3363 | 2317320 |
| Pain | 939.17 | 68.85 | 895 | 36507 | 60962 | 2259721 |
| Frequent bowel movements | 921.57 | 68.85 | 286 | 37116 | 1668 | 2319015 |
| Dyspepsia | 872.36 | 68.85 | 427 | 36975 | 9417 | 2311266 |
| Malaise | 854.21 | 68.85 | 810 | 36592 | 54775 | 2265908 |
| Fatigue | 839.71 | 68.85 | 977 | 36425 | 83896 | 2236787 |
| Pruritus | 801.38 | 68.85 | 701 | 36701 | 42639 | 2278044 |
| Upper respiratory tract infection | 766.44 | 68.85 | 378 | 37024 | 8473 | 2312210 |
| Gastrointestinal disorder | 687.38 | 68.85 | 352 | 37050 | 8565 | 2312118 |
| Therapeutic product effect decreased | 600.07 | 68.85 | 343 | 37059 | 10446 | 2310237 |
| Nasopharyngitis | 594.13 | 68.85 | 445 | 36957 | 21611 | 2299072 |
| Therapeutic response decreased | 592.33 | 68.85 | 297 | 37105 | 6898 | 2313785 |
| Muscle spasms | 573.95 | 68.85 | 432 | 36970 | 21134 | 2299549 |
| Stress | 558.24 | 68.85 | 282 | 37120 | 6656 | 2314027 |
| Dizziness | 502.65 | 68.85 | 629 | 36773 | 58036 | 2262647 |
| Sinusitis | 475.31 | 68.85 | 347 | 37055 | 16179 | 2304504 |
| Tension headache | 458.68 | 68.85 | 125 | 37277 | 417 | 2320266 |
| Alopecia | 446.61 | 68.85 | 376 | 37026 | 21625 | 2299058 |
| Cough | 437.20 | 68.85 | 445 | 36957 | 32672 | 2288011 |
| Gastrooesophageal reflux disease | 411.04 | 68.85 | 253 | 37149 | 8842 | 2311841 |
| Influenza | 408.64 | 68.85 | 288 | 37114 | 12690 | 2307993 |
| Memory impairment | 386.63 | 68.85 | 278 | 37124 | 12645 | 2308038 |
| Abdominal pain | 370.74 | 68.85 | 415 | 36987 | 33959 | 2286724 |
| Flatulence | 367.03 | 68.85 | 185 | 37217 | 4340 | 2316343 |
| Faeces soft | 355.09 | 68.85 | 98 | 37304 | 347 | 2320336 |
| Pain in extremity | 350.91 | 68.85 | 448 | 36954 | 42092 | 2278591 |
| Back pain | 334.12 | 68.85 | 378 | 37024 | 31281 | 2289402 |
| Unevaluable event | 328.87 | 68.85 | 218 | 37184 | 8673 | 2312010 |
| Arthropathy | 321.60 | 68.85 | 200 | 37202 | 7116 | 2313567 |
| Anxiety | 290.28 | 68.85 | 339 | 37063 | 29020 | 2291663 |
| Bronchitis | 285.55 | 68.85 | 238 | 37164 | 13476 | 2307207 |
| Peripheral swelling | 283.55 | 68.85 | 264 | 37138 | 17333 | 2303350 |
| Condition aggravated | 265.41 | 68.85 | 338 | 37064 | 31641 | 2289042 |
| Therapeutic product effect incomplete | 247.12 | 68.85 | 196 | 37206 | 10335 | 2310348 |
| Arthritis | 245.73 | 68.85 | 191 | 37211 | 9777 | 2310906 |
| Feeling abnormal | 244.29 | 68.85 | 279 | 37123 | 23302 | 2297381 |
| Abdominal distension | 236.26 | 68.85 | 190 | 37212 | 10221 | 2310462 |
| Rhinorrhoea | 223.40 | 68.85 | 161 | 37241 | 7339 | 2313344 |
| Mood altered | 204.44 | 68.85 | 106 | 37296 | 2640 | 2318043 |
| Tremor | 186.67 | 68.85 | 228 | 37174 | 20433 | 2300250 |
| Enthesopathy | 186.56 | 68.85 | 48 | 37354 | 119 | 2320564 |
| Discomfort | 179.90 | 68.85 | 122 | 37280 | 5037 | 2315646 |
| Gastroenteritis viral | 174.93 | 68.85 | 93 | 37309 | 2441 | 2318242 |
| Urinary tract infection | 174.29 | 68.85 | 267 | 37135 | 29675 | 2291008 |
| Depressed mood | 171.98 | 68.85 | 119 | 37283 | 5079 | 2315604 |
| Dry skin | 171.64 | 68.85 | 131 | 37271 | 6521 | 2314162 |
| Suicidal ideation | 168.29 | 68.85 | 161 | 37241 | 10926 | 2309757 |
| Myalgia | 163.26 | 68.85 | 227 | 37175 | 23106 | 2297577 |
| Loss of personal independence in daily activities | 160.41 | 68.85 | 115 | 37287 | 5196 | 2315487 |
| Treatment failure | 159.73 | 68.85 | 130 | 37272 | 7109 | 2313574 |
| Nasal congestion | 155.60 | 68.85 | 126 | 37276 | 6840 | 2313843 |
| Rash pruritic | 155.16 | 68.85 | 130 | 37272 | 7405 | 2313278 |
| Therapy cessation | 153.54 | 68.85 | 111 | 37291 | 5082 | 2315601 |
| Musculoskeletal stiffness | 153.00 | 68.85 | 160 | 37242 | 12087 | 2308596 |
| Skin exfoliation | 149.32 | 68.85 | 114 | 37288 | 5676 | 2315007 |
| Joint swelling | 149.30 | 68.85 | 184 | 37218 | 16635 | 2304048 |
| Constipation | 146.21 | 68.85 | 207 | 37195 | 21422 | 2299261 |
| Drug intolerance | 141.44 | 68.85 | 162 | 37240 | 13555 | 2307128 |
| Ear infection | 128.68 | 68.85 | 85 | 37317 | 3356 | 2317327 |
| Hypersensitivity | 128.34 | 68.85 | 204 | 37198 | 23389 | 2297294 |
| Palpitations | 127.07 | 68.85 | 168 | 37234 | 16288 | 2304395 |
| Rheumatoid arthritis | 117.43 | 68.85 | 175 | 37227 | 18965 | 2301718 |
| Multiple allergies | 111.84 | 68.85 | 49 | 37353 | 826 | 2319857 |
| Sinus headache | 110.60 | 68.85 | 50 | 37352 | 911 | 2319772 |
| Pregnancy | 108.60 | 68.85 | 109 | 37293 | 7840 | 2312843 |
| Sinus disorder | 104.64 | 68.85 | 68 | 37334 | 2610 | 2318073 |
| Skin discolouration | 104.38 | 68.85 | 90 | 37312 | 5330 | 2315353 |
| Incorrect dose administered | 104.17 | 68.85 | 117 | 37285 | 9578 | 2311105 |
| Mood swings | 103.82 | 68.85 | 73 | 37329 | 3196 | 2317487 |
| Synovitis | 101.11 | 68.85 | 67 | 37335 | 2659 | 2318024 |
| Retching | 101.03 | 68.85 | 61 | 37341 | 2053 | 2318630 |
| Rebound psoriasis | 98.22 | 68.85 | 21 | 37381 | 12 | 2320671 |
| Infection | 95.42 | 68.85 | 154 | 37248 | 17875 | 2302808 |
| Crying | 92.88 | 68.85 | 77 | 37325 | 4319 | 2316364 |
| Nephrolithiasis | 90.67 | 68.85 | 77 | 37325 | 4466 | 2316217 |
| Respiratory tract infection | 90.22 | 68.85 | 73 | 37329 | 3956 | 2316727 |
| Blood pressure increased | 89.77 | 68.85 | 145 | 37257 | 16841 | 2303842 |
| Tenosynovitis | 86.35 | 68.85 | 35 | 37367 | 481 | 2320202 |
| Back disorder | 83.23 | 68.85 | 49 | 37353 | 1573 | 2319110 |
| Defaecation urgency | 82.78 | 68.85 | 32 | 37370 | 385 | 2320298 |
| Therapy partial responder | 80.71 | 68.85 | 31 | 37371 | 366 | 2320317 |
| Irritable bowel syndrome | 80.01 | 68.85 | 50 | 37352 | 1791 | 2318892 |
| Diverticulitis | 79.87 | 68.85 | 69 | 37333 | 4096 | 2316587 |
| Joint stiffness | 77.86 | 68.85 | 67 | 37335 | 3956 | 2316727 |
| Irritability | 76.74 | 68.85 | 82 | 37320 | 6345 | 2314338 |
| Urticaria | 75.43 | 68.85 | 165 | 37237 | 24096 | 2296587 |
| Rash macular | 74.91 | 68.85 | 62 | 37340 | 3469 | 2317214 |
| Skin disorder | 73.40 | 68.85 | 62 | 37340 | 3569 | 2317114 |
| Adverse event | 73.15 | 68.85 | 87 | 37315 | 7572 | 2313111 |
| Feeling jittery | 72.90 | 68.85 | 48 | 37354 | 1884 | 2318799 |
| Eructation | 72.81 | 68.85 | 40 | 37362 | 1122 | 2319561 |
| Oropharyngeal pain | 70.17 | 68.85 | 105 | 37297 | 11413 | 2309270 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diarrhoea | 10782.36 | 88.23 | 3957 | 16796 | 49895 | 1676133 |
| Psoriasis | 9124.44 | 88.23 | 2450 | 18303 | 9175 | 1716853 |
| Nausea | 6260.54 | 88.23 | 2659 | 18094 | 48537 | 1677491 |
| Headache | 6028.81 | 88.23 | 2319 | 18434 | 32057 | 1693971 |
| Drug ineffective | 4105.07 | 88.23 | 2136 | 18617 | 61665 | 1664363 |
| Abdominal discomfort | 3712.71 | 88.23 | 1161 | 19592 | 7920 | 1718108 |
| Product dose omission | 3262.26 | 88.23 | 1331 | 19422 | 21109 | 1704919 |
| Psoriatic arthropathy | 2013.86 | 88.23 | 534 | 20219 | 1769 | 1724259 |
| Depression | 1663.31 | 88.23 | 761 | 19992 | 15908 | 1710120 |
| Weight decreased | 1444.01 | 88.23 | 763 | 19990 | 21990 | 1704038 |
| Abdominal pain upper | 1270.17 | 88.23 | 557 | 20196 | 10444 | 1715584 |
| Adverse drug reaction | 1165.68 | 88.23 | 415 | 20338 | 4323 | 1721705 |
| Therapy non-responder | 907.23 | 88.23 | 373 | 20380 | 5893 | 1720135 |
| Rash | 715.40 | 88.23 | 602 | 20151 | 38091 | 1687937 |
| Frequent bowel movements | 702.02 | 88.23 | 213 | 20540 | 1261 | 1724767 |
| Therapeutic product effect decreased | 614.39 | 88.23 | 284 | 20469 | 6013 | 1720015 |
| Gastric disorder | 575.26 | 88.23 | 194 | 20559 | 1684 | 1724344 |
| Arthralgia | 554.35 | 88.23 | 422 | 20331 | 23022 | 1703006 |
| Fatigue | 457.03 | 88.23 | 534 | 20219 | 50247 | 1675781 |
| Decreased appetite | 441.01 | 88.23 | 372 | 20381 | 23499 | 1702529 |
| Therapeutic response decreased | 423.62 | 88.23 | 211 | 20542 | 5289 | 1720739 |
| Insomnia | 419.93 | 88.23 | 309 | 20444 | 15967 | 1710061 |
| Gastrointestinal disorder | 413.16 | 88.23 | 198 | 20555 | 4550 | 1721478 |
| Dyspepsia | 400.99 | 88.23 | 197 | 20556 | 4788 | 1721240 |
| Vomiting | 386.73 | 88.23 | 428 | 20325 | 37887 | 1688141 |
| Pain | 376.43 | 88.23 | 357 | 20396 | 26300 | 1699728 |
| Flatulence | 358.39 | 88.23 | 155 | 20598 | 2779 | 1723249 |
| Pruritus | 356.71 | 88.23 | 326 | 20427 | 22896 | 1703132 |
| Memory impairment | 355.30 | 88.23 | 200 | 20553 | 6463 | 1719565 |
| Faeces soft | 354.97 | 88.23 | 93 | 20660 | 286 | 1725742 |
| Nasopharyngitis | 306.23 | 88.23 | 211 | 20542 | 9799 | 1716229 |
| Upper respiratory tract infection | 288.64 | 88.23 | 148 | 20605 | 3945 | 1722083 |
| Dizziness | 274.87 | 88.23 | 341 | 20412 | 34020 | 1692008 |
| Mood altered | 265.32 | 88.23 | 114 | 20639 | 2008 | 1724020 |
| Malaise | 243.72 | 88.23 | 298 | 20455 | 29267 | 1696761 |
| Migraine | 233.74 | 88.23 | 107 | 20646 | 2204 | 1723824 |
| Tension headache | 230.07 | 88.23 | 61 | 20692 | 199 | 1725829 |
| Abdominal pain | 217.80 | 88.23 | 241 | 20512 | 21249 | 1704779 |
| Enthesopathy | 187.20 | 88.23 | 43 | 20710 | 59 | 1725969 |
| Muscle spasms | 179.71 | 88.23 | 164 | 20589 | 11457 | 1714571 |
| Anxiety | 178.09 | 88.23 | 186 | 20567 | 15341 | 1710687 |
| Unevaluable event | 176.31 | 88.23 | 124 | 20629 | 5942 | 1720086 |
| Feeling abnormal | 169.58 | 88.23 | 156 | 20597 | 11010 | 1715018 |
| Back pain | 164.23 | 88.23 | 184 | 20569 | 16429 | 1709599 |
| Treatment failure | 161.54 | 88.23 | 104 | 20649 | 4297 | 1721731 |
| Arthritis | 161.06 | 88.23 | 100 | 20653 | 3875 | 1722153 |
| Sinusitis | 159.34 | 88.23 | 110 | 20643 | 5113 | 1720915 |
| Influenza | 157.53 | 88.23 | 121 | 20632 | 6646 | 1719382 |
| Arthropathy | 149.81 | 88.23 | 85 | 20668 | 2782 | 1723246 |
| Rhinorrhoea | 147.31 | 88.23 | 94 | 20659 | 3823 | 1722205 |
| Discomfort | 145.46 | 88.23 | 81 | 20672 | 2555 | 1723473 |
| Cough | 144.35 | 88.23 | 185 | 20568 | 19012 | 1707016 |
| Suicidal ideation | 143.10 | 88.23 | 126 | 20627 | 8392 | 1717636 |
| Tenosynovitis | 137.50 | 88.23 | 42 | 20711 | 254 | 1725774 |
| C-reactive protein abnormal | 137.42 | 88.23 | 41 | 20712 | 226 | 1725802 |
| Loss of personal independence in daily activities | 130.42 | 88.23 | 73 | 20680 | 2326 | 1723702 |
| Therapeutic product effect incomplete | 125.87 | 88.23 | 97 | 20656 | 5351 | 1720677 |
| Depressed mood | 125.03 | 88.23 | 77 | 20676 | 2939 | 1723089 |
| Peripheral swelling | 124.16 | 88.23 | 113 | 20640 | 7858 | 1718170 |
| Mood swings | 120.06 | 88.23 | 65 | 20688 | 1937 | 1724091 |
| Drug intolerance | 114.67 | 88.23 | 96 | 20657 | 5966 | 1720062 |
| Abdominal distension | 111.58 | 88.23 | 97 | 20656 | 6347 | 1719681 |
| Pain in extremity | 109.98 | 88.23 | 159 | 20594 | 18313 | 1707715 |
| Gastrooesophageal reflux disease | 107.92 | 88.23 | 83 | 20670 | 4564 | 1721464 |
| Synovitis | 106.36 | 88.23 | 44 | 20709 | 701 | 1725327 |
| Stress | 103.33 | 88.23 | 65 | 20688 | 2576 | 1723452 |
| Skin exfoliation | 94.52 | 88.23 | 76 | 20677 | 4459 | 1721569 |
| Dry skin | 92.15 | 88.23 | 69 | 20684 | 3643 | 1722385 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L04AA32 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants |
| CHEBI has role | CHEBI:35475 | non-steroidal anti-inflammatory drug |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D018712 | Analgesics, Non-Narcotic |
| MeSH PA | D000893 | Anti-Inflammatory Agents |
| MeSH PA | D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| MeSH PA | D018501 | Antirheumatic Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D018689 | Sensory System Agents |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Psoriasis with arthropathy | indication | 33339001 | |
| Plaque psoriasis | indication | 200965009 | |
| Behçet's disease affecting oral mucosa | indication | 403443000 |
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4 |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7208516 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8802717 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4 |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7208516 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8802717 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 6962940 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4 |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7208516 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 7659302 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8455536 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 8802717 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9018243 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9724330 | March 19, 2023 | USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 10092541 | May 29, 2034 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE USING A DOSAGE TITRATION SCHEDULE |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 10092541 | May 29, 2034 | TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9872854 | May 29, 2034 | TREATMENT OF PSORIATIC ARTHRITIS USING A DOSAGE TITRATION SCHEDULE |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9872854 | May 29, 2034 | TREATMENT OF PSORIATIC ARTHRITIS WITH APREMILAST USING A DOSAGE TITRATION SCHEDULE AND A SECOND ACTIVE AGENT |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 10092541 | May 29, 2034 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE USING A DOSAGE TITRATION SCHEDULE |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 10092541 | May 29, 2034 | TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9872854 | May 29, 2034 | TREATMENT OF PSORIATIC ARTHRITIS USING A DOSAGE TITRATION SCHEDULE |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9872854 | May 29, 2034 | TREATMENT OF PSORIATIC ARTHRITIS WITH APREMILAST USING A DOSAGE TITRATION SCHEDULE AND A SECOND ACTIVE AGENT |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 10092541 | May 29, 2034 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE USING A DOSAGE TITRATION SCHEDULE |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 10092541 | May 29, 2034 | TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9872854 | May 29, 2034 | TREATMENT OF PSORIATIC ARTHRITIS USING A DOSAGE TITRATION SCHEDULE |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | 9872854 | May 29, 2034 | TREATMENT OF PSORIATIC ARTHRITIS WITH APREMILAST USING A DOSAGE TITRATION SCHEDULE AND A SECOND ACTIVE AGENT |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | July 19, 2022 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | July 19, 2022 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | July 19, 2022 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE |
| 10MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | July 19, 2026 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE |
| 20MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | July 19, 2026 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE |
| 30MG | OTEZLA | AMGEN INC | N205437 | March 21, 2014 | RX | TABLET | ORAL | July 19, 2026 | TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| cAMP-specific 3',5'-cyclic phosphodiesterase 4D | Enzyme | INHIBITOR | IC50 | 7.13 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| cAMP-specific 3',5'-cyclic phosphodiesterase 4A | Enzyme | INHIBITOR | IC50 | 7.85 | IUPHAR | ||||
| cAMP-specific 3',5'-cyclic phosphodiesterase 4C | Enzyme | INHIBITOR | IC50 | 6.93 | IUPHAR | ||||
| cAMP-specific 3',5'-cyclic phosphodiesterase 4B | Enzyme | INHIBITOR | IC50 | 7.57 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| D08860 | KEGG_DRUG |
| 4033216 | VUID |
| N0000190644 | NUI |
| C1678805 | UMLSCUI |
| 714684002 | SNOMEDCT_US |
| 1492727 | RXNORM |
| 015411 | NDDF |
| 30225 | MMSL |
| d08247 | MMSL |
| 4033216 | VANDF |
| 703350008 | SNOMEDCT_US |
| 11561674 | PUBCHEM_CID |
| CHEBI:78540 | CHEBI |
| CHEMBL514800 | ChEMBL_ID |
| UP7QBP99PN | UNII |
| 8872 | INN_ID |
| DB05676 | DRUGBANK_ID |
| 7372 | IUPHAR_LIGAND_ID |
| C505730 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Otezla | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-137 | TABLET, FILM COATED | 30 mg | ORAL | NDA | 17 sections |
| Otezla | HUMAN PRESCRIPTION DRUG LABEL | 3 | 55513-369 | KIT | 20 mg | None | NDA | 17 sections |
| Otezla | HUMAN PRESCRIPTION DRUG LABEL | 3 | 55513-369 | KIT | 10 mg | None | NDA | 17 sections |
| Otezla | HUMAN PRESCRIPTION DRUG LABEL | 3 | 55513-369 | KIT | 30 mg | None | NDA | 17 sections |
| Otezla | HUMAN PRESCRIPTION DRUG LABEL | 3 | 55513-485 | KIT | 20 mg | None | NDA | 17 sections |
| Otezla | HUMAN PRESCRIPTION DRUG LABEL | 3 | 55513-485 | KIT | 30 mg | None | NDA | 17 sections |
| Otezla | HUMAN PRESCRIPTION DRUG LABEL | 3 | 55513-485 | KIT | 10 mg | None | NDA | 17 sections |
| OTEZLA | HUMAN PRESCRIPTION DRUG LABEL | 3 | 59572-630 | KIT | 20 mg | ORAL | NDA | 17 sections |
| OTEZLA | HUMAN PRESCRIPTION DRUG LABEL | 3 | 59572-630 | KIT | 30 mg | ORAL | NDA | 17 sections |
| OTEZLA | HUMAN PRESCRIPTION DRUG LABEL | 3 | 59572-630 | KIT | 10 mg | ORAL | NDA | 17 sections |
| OTEZLA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59572-631 | TABLET, FILM COATED | 30 mg | ORAL | NDA | 17 sections |
| OTEZLA | HUMAN PRESCRIPTION DRUG LABEL | 3 | 59572-632 | KIT | 20 mg | ORAL | NDA | 17 sections |
| OTEZLA | HUMAN PRESCRIPTION DRUG LABEL | 3 | 59572-632 | KIT | 10 mg | ORAL | NDA | 17 sections |
| OTEZLA | HUMAN PRESCRIPTION DRUG LABEL | 3 | 59572-632 | KIT | 30 mg | ORAL | NDA | 17 sections |