Calendar

pharmadog

Week of Oct 6, 2025

Oct 6, 2025approval313d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Oct 6, 2025approval313d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Oct 6, 2025approval313d agoLIDOCAINE — FDA approvalSustained Therapeutics Inc

Sponsor: ALKEM LABS LTD. Form: PATCH. Route: TOPICAL

full page →fda approvals ↗

Oct 6, 2025approval313d agoLITHIUM CARBONATE — FDA approvalCamber Pharmaceuticals Inc

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 6, 2025approval313d agoBUSPIRONE HYDROCHLORIDE — FDA approvalBUSPIRONE HYDROCHLORIDE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →BUSPIRONE HYDROCHLORIDE →fda approvals ↗

Oct 6, 2025approval313d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

Sponsor: HISAMITSU PHARM CO. Form: PATCH. Route: TOPICAL

full page →fda approvals ↗

Oct 6, 2025approval313d agoLITHIUM CARBONATE — FDA approvalCamber Pharmaceuticals Inc

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 6, 2025approval313d agoOLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE) — FDA approvalamlodipine besylate

Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL

full page →amlodipine besylate →fda approvals ↗

Oct 7, 2025approval312d agoJASCAYD (NERANDOMILAST) — FDA approvalnerandomilast

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →nerandomilast →fda approvals ↗

Oct 7, 2025approval312d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 7, 2025approval312d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 7, 2025approval312d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

full page →remdesivir →fda approvals ↗

Oct 7, 2025approval312d agoEXEMESTANE — FDA approvalEXEMESTANE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →EXEMESTANE →fda approvals ↗

Oct 7, 2025approval312d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLIN ER →fda approvals ↗

Oct 7, 2025approval312d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

Sponsor: TARO. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Oct 7, 2025approval312d agoFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) — FDA approvalfexofenadine hydrochloride

Sponsor: L PERRIGO CO. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fexofenadine hydrochloride →fda approvals ↗

Oct 7, 2025approval312d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

Oct 7, 2025approval312d agoRIVAROXABAN — FDA approvalJohnson & Johnson Innovative Medicine

Sponsor: TARO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 7, 2025approval312d agoLASIX ONYU (FUROSEMIDE) — FDA approvalFurosemide Sun

Sponsor: SQ INNOVATION. Form: SOLUTION. Route: SUBCUTANEOUS

full page →Furosemide Sun →fda approvals ↗

Oct 8, 2025approval311d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

full page →RIFADIN →fda approvals ↗

Oct 8, 2025approval311d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

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

full page →RIFATER →fda approvals ↗

Oct 8, 2025approval311d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

full page →RIFADIN →fda approvals ↗

Oct 8, 2025approval311d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

full page →amivantamab →fda approvals ↗

Oct 8, 2025approval311d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

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

full page →cemiplimab →fda approvals ↗

Oct 8, 2025approval311d agoTRIAMCINOLONE ACETONIDE — FDA approvaltriamcinolone acetonide Rising

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →triamcinolone acetonide Rising →fda approvals ↗

Oct 8, 2025approval311d agoLUPKYNIS (VOCLOSPORIN) — FDA approvalvoclosporin

Sponsor: AURINIA. Form: CAPSULE. Route: ORAL

full page →voclosporin →fda approvals ↗

Oct 8, 2025approval311d agoORGOVYX (RELUGOLIX) — FDA approvalrelugolix

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

full page →relugolix →fda approvals ↗

Oct 8, 2025recall311d 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, 2025recall311d 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, 2025recall311d 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, 2025recall311d 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, 2025recall311d 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, 2025approval310d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Oct 9, 2025approval310d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Oct 9, 2025approval310d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

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

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 9, 2025approval310d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Oct 9, 2025approval310d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Oct 9, 2025approval310d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Oct 9, 2025approval310d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

full page →alirocumab →fda approvals ↗

Oct 9, 2025approval310d agoCABOMETYX (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

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

full page →cabozantinib s-malate →fda approvals ↗

Oct 9, 2025approval310d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Oct 9, 2025approval310d agoCOMETRIQ (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗

Oct 9, 2025approval310d agoTRAVATAN Z (TRAVOPROST) — FDA approvalTRAVOPROST

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

full page →TRAVOPROST →fda approvals ↗

Oct 9, 2025approval310d agoIXIFI (INFLIXIMAB-QBTX) — FDA approvalIXIFI

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

full page →IXIFI →fda approvals ↗

Oct 9, 2025approval310d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Oct 9, 2025approval310d agoPEMETREXED DISODIUM — FDA approvalLilly USA LLC

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

full page →fda approvals ↗

Oct 9, 2025approval310d agoZIPRASIDONE MESYLATE — FDA approvalZIPRASIDONE MESYLATE

Sponsor: GLAND. Form: POWDER. Route: INTRAMUSCULAR

full page →ZIPRASIDONE MESYLATE →fda approvals ↗

Oct 9, 2025approval310d agoLANOXIN PEDIATRIC (DIGOXIN) — FDA approvalDIGOXIN

Sponsor: AZURITY. Form: INJECTABLE. Route: INJECTION

full page →DIGOXIN →fda approvals ↗

Oct 9, 2025approval310d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

Oct 10, 2025approval309d agoISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

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Week of Oct 6, 2025