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Week of Oct 6, 2025

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Oct 8, 2025approval310d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

full page →RIFADIN →fda approvals ↗

Oct 8, 2025approval310d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →RIFATER →fda approvals ↗

Oct 8, 2025approval310d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

full page →RIFADIN →fda approvals ↗

Oct 8, 2025approval310d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →amivantamab →fda approvals ↗

Oct 8, 2025approval310d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INTRAVENOUS

full page →cemiplimab →fda approvals ↗

Oct 8, 2025approval310d agoTRIAMCINOLONE ACETONIDE — FDA approvaltriamcinolone acetonide Rising

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →triamcinolone acetonide Rising →fda approvals ↗

Oct 8, 2025approval310d agoLUPKYNIS (VOCLOSPORIN) — FDA approvalvoclosporin

Sponsor: AURINIA. Form: CAPSULE. Route: ORAL

full page →voclosporin →fda approvals ↗

Oct 8, 2025approval310d agoORGOVYX (RELUGOLIX) — FDA approvalrelugolix

Sponsor: SUMITOMO PHARMA AM. Form: TABLET. Route: ORAL

full page →relugolix →fda approvals ↗

Oct 8, 2025recall310d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. — Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity — Status: Ongoing

full page →fda recalls ↗

Oct 8, 2025recall310d agoApotex Corp. recall (Cls II)Apotex Corp

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL). — Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns — Status: Ongoing

full page →fda recalls ↗

Oct 8, 2025recall310d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. — Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity — Status: Ongoing

full page →fda recalls ↗

Oct 8, 2025recall310d agoApotex Corp. recall (Cls II)Apotex Corp

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1. — Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns — Status: Ongoing

full page →fda recalls ↗

Oct 8, 2025recall310d agoAmerisource Health Services LLC recall (Cls II)Teva Pharmaceuticals USA Inc

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11) — Reason: Failed Dissolution Specifications. — Status: Ongoing

full page →fda recalls ↗

Oct 9, 2025approval309d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

Oct 9, 2025approval309d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 9, 2025approval309d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

Sponsor: ASCENT PHARMS INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 9, 2025approval309d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 9, 2025approval309d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 9, 2025approval309d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: ANDA REPOSITORY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 9, 2025approval309d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →alirocumab →fda approvals ↗

Oct 9, 2025approval309d agoCABOMETYX (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS INC. Form: TABLET. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗

Oct 9, 2025approval309d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Oct 9, 2025approval309d agoCOMETRIQ (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗

Oct 9, 2025approval309d agoTRAVATAN Z (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: SANDOZ. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →TRAVOPROST →fda approvals ↗

Oct 9, 2025approval309d agoIXIFI (INFLIXIMAB-QBTX) — FDA approvalIXIFI

Sponsor: PFIZER INC. Form: INJECTABLE. Route: INJECTION

full page →IXIFI →fda approvals ↗

Oct 9, 2025approval309d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Oct 9, 2025approval309d agoPEMETREXED DISODIUM — FDA approvalLilly USA LLC

Sponsor: RELIANCE LIFE. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 9, 2025approval309d agoZIPRASIDONE MESYLATE — FDA approvalZIPRASIDONE MESYLATE

Sponsor: GLAND. Form: POWDER. Route: INTRAMUSCULAR

full page →ZIPRASIDONE MESYLATE →fda approvals ↗

Oct 9, 2025approval309d agoLANOXIN PEDIATRIC (DIGOXIN) — FDA approvalDIGOXIN

Sponsor: AZURITY. Form: INJECTABLE. Route: INJECTION

full page →DIGOXIN →fda approvals ↗

Oct 9, 2025approval309d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: SUN PHARMA CANADA. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Oct 10, 2025approval308d agoISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 10, 2025approval308d agoISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 10, 2025approval308d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 10, 2025approval308d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2025approval308d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2025approval308d agoERRIN (NORETHINDRONE) — FDA approvalNaari USA Inc

Sponsor: DR REDDYS LABS SA. Form: TABLET. Route: ORAL-28

full page →fda approvals ↗

Oct 10, 2025approval308d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoUNITUXIN (DINUTUXIMAB) — FDA approvalUNITED THERAPEUTICS Corp

Sponsor: UNITED THERAP. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 10, 2025approval308d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →fda approvals ↗

Oct 10, 2025approval308d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →fda approvals ↗

Oct 10, 2025approval308d agoGALLIUM GA 68 EDOTREOTIDE (GALLIUM GA-68 EDOTREOTIDE) — FDA approval

Sponsor: METHODIST. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 10, 2025approval308d agoRINVOQ LQ (UPADACITINIB) — FDA approvalupadacitinib

Sponsor: ABBVIE. Form: SOLUTION. Route: ORAL

full page →upadacitinib →fda approvals ↗

Oct 10, 2025approval308d agoONGENTYS (OPICAPONE) — FDA approvalopicapone

Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL

full page →opicapone →fda approvals ↗

Oct 10, 2025approval308d agoOLPRUVA (SODIUM PHENYLBUTYRATE) — FDA approvalSODIUM PHENYLBUTYRATE

Sponsor: ACER. Form: FOR SUSPENSION. Route: ORAL

full page →SODIUM PHENYLBUTYRATE →fda approvals ↗

Oct 10, 2025approval308d agoCHLORPROMAZINE HYDROCHLORIDE — FDA approvalFosun Pharma USA Inc

Sponsor: RUBICON. Form: CONCENTRATE. Route: ORAL

full page →fda approvals ↗

Oct 10, 2025approval308d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

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