HEALTH CARE PROVIDER LETTER SECTION.

Important Prescribing Information. May2024Subject: Temporary importation of TEGLUTIK (riluzole oral suspension, mg/mL) with English labeling to address drug shortage in the United States Dear Health Care Provider,The purpose of this letter is to inform you about temporary importation in the United States (U.S.) of TEGLUTIK (riluzole mg/mL oral suspension) with bottle and carton labels in English, in coordination with the U.S. Food and Drug Administration (FDA) to mitigate the current shortage of FDA-approved Tiglutik (riluzole oral suspension, 50 mg/10 mL) in the U.S. This temporary supply of TEGLUTIK is marketed and manufactured by Italfarmaco in Spain and is not FDA-approved.Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Recently, Tiglutik was recalled in the U.S. market due to an out-of-specification test result for viscosity.At this time, no other entity except EDW Pharma, Inc. (formerly Italfarmaco (ITF) Pharma, Inc.) is authorized by the FDA to import or distribute Italfarmacos TEGLUTIK riluzole oral suspension in the U.S. Effective immediately, and during this temporary period, EDW Pharma, Inc. will distribute the following presentation of riluzole oral suspension to address the critical shortage: Product NameQuantityDescriptionsU.S. NDC numberLot NumberExpiration DateTEGLUTIKriluzole oral cartonsuspension(5 mg/mL)1 bottle per cartonTeglutik is presentedas slightly brown,opaque homogeneous oralsuspension after beingmanually gently shaken.TEGLUTIK isavailable in bottleof 300 ml with aplastic graduated oral dosingsyringe. Thesyringe barrel isgraduated inmilliliters up to 10 ml.70726-0306-12400804/2027The safety profiles of the FDA-approved Tiglutik and imported TEGLUTIK products are comparable and no specific safety concerns emerged from the comparison of the two products. Please refer to the side-by-side comparison of the labels (enclosed) for additional information. Tiglutik is available only by prescription in the U.S. The imported lot does not have the statement Rx only on its labeling. The barcode on the imported product label may not register accurately on the U.S. scanning systems. Institutions should manually input the imported product information into their systems and confirm that the barcode, if scanned, provides correct information. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients. In addition, the package of the imported product does not include product identifier as required under the Drug Supply Chain Security Act (DSCSA). Specifically, each package does not include the NDC, unique serial number, lot number, and expiration date in both human- readable and two-dimensional data matrix barcode. Additionally, the imported product may not be accompanied with DSCSA-required product tracing documentation (transaction information, transaction history, and transaction statement). Reporting Adverse EventsHealth care providers and patients are encouraged to report adverse events and medication errors in patients taking TEGLUTIK to AnovoRx at 1-844-763-1198. You are encouraged to report negative side effects of prescription drugs to the FDA.Adverse events or quality problems experienced with the use of this product may also be reported to the FDAs MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax:Complete and submit the report Online: www.fda.gov/medwatch/report.htmRegular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178 (1-800-332-0178).You may also contact AnovoRx at 1-844-763-1198 if you have any questions about the information contained in this letter or the safe and effective use of TEGLUTIK.This letter is not intended as complete description of the benefits and risks related to the use of TEGLUTIK. Please refer to the enclosed TEGLUTIK SmPC and Tiglutik USPI side-by- side comparison.For additional information, please visit www.tiglutik.com and www.edwpharma.com.Sincerely,Peter CookCEO and PresidentEDW Pharma, Inc. (Formerly ITF Pharma, Inc.)(UK Bottle TEXT)(u.s. BOTTLE label TEXT)NAME OF THE MEDICINAL PRODUCTTEGLUTIK mg/ml oral suspension riluzole NAME OF THE MEDICINAL PRODUCTTIGLUTIK(R) riluzole oral suspension 50mg/10ml(5mg/ml) STATEMENT OF ACTIVE SUBSTANCE(S)1 ml contains: mg of riluzoleSTATEMENT OF ACTIVE SUBSTANCE(S)Contains: TIGLUTIK(R) 50 mg/10 mL (5 mg/mL)LIST OF EXCIPIENTSAlso contains: liquid sorbitol (E420)-------PHARMACEUTICAL FORM AND CONTENTSOral suspensionBottle of 300 mlPHARMACEUTICAL FORM AND CONTENTSs product is ling Information.TIGLUTIK(R) 50 mg/10 mL (5 mg/mL) oral suspension is slightly brown, opaque,homogeneous suspension when mixed, containing 50 mg of riluzole per 10 mL of suspensionMETHOD AND ROUTE(S) OF ADMINISTRATIONRead the package leaflet before useOral useAdministration via enteral feeding tubesShake gently before useMETHOD AND ROUTE(S) OF ADMINISTRATIONBefore use, please read the enclosed Prescribing Information.For oral administrationShake gently before useThe bottle must be gently shaken for at least 30 seconds by continuously rotating the bottle 180 until the visual appearance of the suspension is homogeneous.DOSAGE-----DOSAGEThe recommended dose is 10 mL of TIGLUTIK(R) oral suspension, containing 50 mg of riluzole, taken orally twice daily, every 12 hours.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDRENKeep out of the sight and reach of childrenSPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDRENKeep out of reach of children.SPECIAL STORAGE CONDITIONSExpiry:Once opened, use within 15 daysSPECIAL STORAGE CONDITIONSStore TIGLUTIK(R) at controlled room temperature between 20-25C (68-77F), excursions permitted to 15-30C (59-86F) and protect from bright light.Do not freeze. Store upright.Once opened, the bottle of TIGLUTIK(R) should be used within 15 days. Keep bottle tightly closed between each use.GENERAL CLASSIFICATION FOR SUPPLYMedicinal product subject to medical prescription Hospital use GENERAL CLASSIFICATION FOR SUPPLYRx onlyNAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDERMarketing Authorization Holder: ITALFARMACO S.A San Rafael, 28108 Alcobendas (Madrid) Spain ITF PharmaManufactured for:ITF Pharma, Inc.Berwyn, PA 19312 USATIGLUTIK is registered trademark of Italfarmaco S.A.(C)2019 ITF Pharma, Inc. All rights reserved.TOCXXXXXX. Complete and submit the report Online: www.fda.gov/medwatch/report.htm. Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178 (1-800-332-0178).. carton. label.