Calendar

Week of Oct 6, 2025

Oct 6, 2025approval328d 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, 2025approval327d agoJASCAYD (NERANDOMILAST) — FDA approvalnerandomilast

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

full page →nerandomilast →fda approvals ↗

Oct 7, 2025approval327d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗

Oct 7, 2025approval327d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

full page →fda approvals ↗

Oct 7, 2025approval327d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

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

full page →remdesivir →fda approvals ↗

Oct 7, 2025approval327d agoEXEMESTANE — FDA approvalEXEMESTANE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →EXEMESTANE →fda approvals ↗

Oct 7, 2025approval327d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

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

full page →METHYLIN ER →fda approvals ↗

Oct 7, 2025approval327d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

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

full page →fda approvals ↗

Oct 7, 2025approval327d 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, 2025approval327d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗

Oct 7, 2025approval327d agoRIVAROXABAN — FDA approvalJohnson & Johnson Innovative Medicine

Sponsor: TARO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 7, 2025approval327d agoLASIX ONYU (FUROSEMIDE) — FDA approvalFurosemide Sun

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

full page →Furosemide Sun →fda approvals ↗

Oct 8, 2025approval326d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

full page →RIFADIN →fda approvals ↗

Oct 8, 2025approval326d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

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

full page →RIFATER →fda approvals ↗

Oct 8, 2025approval326d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

full page →RIFADIN →fda approvals ↗

Oct 8, 2025approval326d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

full page →amivantamab →fda approvals ↗

Oct 8, 2025approval326d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

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

full page →cemiplimab →fda approvals ↗

Oct 8, 2025approval326d agoTRIAMCINOLONE ACETONIDE — FDA approvaltriamcinolone acetonide Rising

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →triamcinolone acetonide Rising →fda approvals ↗

Oct 8, 2025approval326d agoLUPKYNIS (VOCLOSPORIN) — FDA approvalvoclosporin

Sponsor: AURINIA. Form: CAPSULE. Route: ORAL

full page →voclosporin →fda approvals ↗

Oct 8, 2025approval326d agoORGOVYX (RELUGOLIX) — FDA approvalrelugolix

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

full page →relugolix →fda approvals ↗

Oct 9, 2025approval325d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Oct 9, 2025approval325d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Oct 9, 2025approval325d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

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

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 9, 2025approval325d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Oct 9, 2025approval325d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Oct 9, 2025approval325d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Oct 9, 2025approval325d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

full page →alirocumab →fda approvals ↗

Oct 9, 2025approval325d agoCABOMETYX (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

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

full page →cabozantinib s-malate →fda approvals ↗

Oct 9, 2025approval325d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Oct 9, 2025approval325d agoCOMETRIQ (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗

Oct 9, 2025approval325d agoTRAVATAN Z (TRAVOPROST) — FDA approvalTRAVOPROST

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

full page →TRAVOPROST →fda approvals ↗

Oct 9, 2025approval325d agoIXIFI (INFLIXIMAB-QBTX) — FDA approvalIXIFI

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

full page →IXIFI →fda approvals ↗

Oct 9, 2025approval325d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Oct 9, 2025approval325d agoPEMETREXED DISODIUM — FDA approvalLilly USA LLC

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

full page →fda approvals ↗

Oct 9, 2025approval325d agoZIPRASIDONE MESYLATE — FDA approvalZIPRASIDONE MESYLATE

Sponsor: GLAND. Form: POWDER. Route: INTRAMUSCULAR

full page →ZIPRASIDONE MESYLATE →fda approvals ↗

Oct 9, 2025approval325d agoLANOXIN PEDIATRIC (DIGOXIN) — FDA approvalDIGOXIN

Sponsor: AZURITY. Form: INJECTABLE. Route: INJECTION

full page →DIGOXIN →fda approvals ↗

Oct 9, 2025approval325d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

Oct 9, 2025grant325d agoUNIVERSITY OF NEW MEXICO — Advancing precision medicine through measurement of reward and relief drinking

AA grant. $39,309. PI: Hanna Marie Hebden

full page →nih reporter ↗

Oct 10, 2025approval324d agoISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 10, 2025approval324d agoISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 10, 2025approval324d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 10, 2025approval324d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2025approval324d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2025approval324d agoERRIN (NORETHINDRONE) — FDA approvalNaari USA Inc

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

full page →fda approvals ↗

Oct 10, 2025approval324d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval324d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval324d agoUNITUXIN (DINUTUXIMAB) — FDA approvalUNITED THERAPEUTICS Corp

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

full page →fda approvals ↗

Oct 10, 2025approval324d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

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

full page →fda approvals ↗

Oct 10, 2025approval324d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

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

full page →fda approvals ↗

Oct 10, 2025approval324d agoGALLIUM GA 68 EDOTREOTIDE (GALLIUM GA-68 EDOTREOTIDE) — FDA approval

Sponsor: METHODIST. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

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Week of Oct 6, 2025