Calendar

pharmadog

Week of Sep 22, 2025

Sep 24, 2025approval339d agoBONDLIDO (LIDOCAINE) — FDA approvalSustained Therapeutics Inc

Sponsor: MEDRX USA. Form: SYSTEM. Route: TOPICAL

full page →fda approvals ↗

Sep 24, 2025approval339d agoHEPARIN SODIUM — FDA approvalHEPARIN SODIUM

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗

Sep 24, 2025approval339d agoVARENICLINE TARTRATE — FDA approvalMylan Pharmaceuticals Inc

Sponsor: NE RX PHARMA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 25, 2025approval338d agoITOVEBI (INAVOLISIB) — FDA approvalinavolisib

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

full page →inavolisib →fda approvals ↗

Sep 25, 2025approval338d agoALYFTREK (DEUTIVACAFTOR) — FDA approval(deutivacaftor + tezacaftor + vanzacaftor calcium)

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →(deutivacaftor + tezacaftor + vanzacaftor calcium) →fda approvals ↗

Sep 25, 2025approval338d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Sep 25, 2025approval338d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

Sponsor: VERTEX PHARMS INC. Form: GRANULES. Route: ORAL

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Sep 25, 2025approval338d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

full page →(ivacaftor + lumacaftor) →fda approvals ↗

Sep 25, 2025approval338d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

Sponsor: VERTEX PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 25, 2025approval338d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

full page →ivacaftor →fda approvals ↗

Sep 25, 2025approval338d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →(ivacaftor + lumacaftor) →fda approvals ↗

Sep 25, 2025approval338d agoSYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approvalivacaftor

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →ivacaftor →fda approvals ↗

Sep 25, 2025approval338d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗

Sep 25, 2025approval338d agoROBINUL (GLYCOPYRROLATE) — FDA approvalGLYCOPYRROLATE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →GLYCOPYRROLATE →fda approvals ↗

Sep 25, 2025approval338d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗

Sep 25, 2025approval338d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

Sep 25, 2025approval338d agoWEZLANA (USTEKINUMAB-AUUB) — FDA approvalWEZLANA

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →WEZLANA →fda approvals ↗

Sep 25, 2025approval338d agoWEZLANA (USTEKINUMAB-AUUB) — FDA approvalWEZLANA

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →WEZLANA →fda approvals ↗

Sep 25, 2025approval338d agoINLURIYO (IMLUNESTRANT TOSYLATE) — FDA approvalimlunestrant tosylate

Sponsor: ELI LILLY AND CO. Form: TABLET. Route: ORAL

full page →imlunestrant tosylate →fda approvals ↗

Sep 25, 2025approval338d agoCEFUROXIME AXETIL — FDA approvalOrchid Pharma Inc

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 25, 2025approval338d agoCEFUROXIME AXETIL — FDA approvalOrchid Pharma Inc

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 25, 2025approval338d agoCEFUROXIME AXETIL — FDA approvalOrchid Pharma Inc

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 25, 2025approval338d agoPALSONIFY (PALTUSOTINE HYDROCHLORIDE) — FDA approvalpaltusotine hydrochloride

Sponsor: CRINETICS. Form: TABLET. Route: ORAL

full page →paltusotine hydrochloride →fda approvals ↗

Sep 25, 2025approval338d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: AVANTHI INC. Form: CAPSULE. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Sep 25, 2025approval338d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: AVANTHI INC. Form: CAPSULE. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Sep 25, 2025approval338d agoEVKEEZA (EVINACUMAB-DGNB) — FDA approvalevinacumab

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

full page →evinacumab →fda approvals ↗

Sep 25, 2025approval338d agoRIVAROXABAN — FDA approvalRIVAROXABAN

Sponsor: LUPIN LTD. Form: FOR SUSPENSION. Route: ORAL

full page →RIVAROXABAN →fda approvals ↗

Sep 26, 2025approval337d agoHYDROCODONE BITARTRATE — FDA approvalhydrocodone bitartrate ER

Sponsor: ALVOGEN. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →hydrocodone bitartrate ER →fda approvals ↗

Sep 26, 2025approval337d agoENOBY (DENOSUMAB-QBDE) — FDA approvalENOBY

Sponsor: HIKMA PHARMACEUTICALS USA INC. Form: SOLUTION. Route: INJECTION

full page →ENOBY →fda approvals ↗

Sep 26, 2025approval337d agoFLUOXETINE HYDROCHLORIDE — FDA approvalEli Lilly and Co

Sponsor: INVENTIA HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 26, 2025approval337d agoFLUOXETINE HYDROCHLORIDE — FDA approvalEli Lilly and Co

Sponsor: INVENTIA HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 26, 2025approval337d agoAMPHETAMINE SULFATE — FDA approvalamfetamine ER

Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

full page →amfetamine ER →fda approvals ↗

Sep 26, 2025approval337d agoPYRIDOSTIGMINE BROMIDE — FDA approvalBausch Health US LLC

Sponsor: US ARMY. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 26, 2025approval337d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Sep 26, 2025approval337d agoCAFFEINE CITRATE — FDA approvalCAFFEINE CITRATE

Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: ORAL

full page →CAFFEINE CITRATE →fda approvals ↗

Sep 26, 2025approval337d agoCELECOXIB — FDA approvalScilex Holding Co

Sponsor: NANJING. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 26, 2025approval337d agoCELECOXIB — FDA approvalScilex Holding Co

Sponsor: NANJING. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 26, 2025approval337d agoCELECOXIB — FDA approvalScilex Holding Co

Sponsor: NANJING. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 26, 2025approval337d agoTIZANIDINE HYDROCHLORIDE — FDA approvalRiconpharma LLC

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 26, 2025approval337d agoLIDOCAINE HYDROCHLORIDE — FDA approvalLaryng-O-Jet

Sponsor: COSETTE. Form: JELLY. Route: TOPICAL

full page →Laryng-O-Jet →fda approvals ↗

Sep 26, 2025approval337d agoAMPHETAMINE SULFATE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 26, 2025approval337d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

full page →guselkumab →fda approvals ↗

Sep 26, 2025approval337d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

full page →guselkumab →fda approvals ↗

Sep 26, 2025approval337d agoQVAR REDIHALER (BECLOMETHASONE DIPROPIONATE) — FDA approvalSOLIGENIX, INC.

Sponsor: NORTON WATERFORD. Form: AEROSOL, METERED. Route: INHALATION

full page →fda approvals ↗

Sep 26, 2025approval337d agoCALCITONIN-SALMON (CALCITONIN SALMON) — FDA approvalcalcitonin

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →calcitonin →fda approvals ↗

Sep 26, 2025approval337d agoAMPHETAMINE SULFATE — FDA approvalAurolife Pharma LLC

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 26, 2025approval337d agoAMPHETAMINE SULFATE — FDA approvalamfetamine ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →amfetamine ER →fda approvals ↗

Sep 26, 2025approval337d agoCLOTIC (CLOTRIMAZOLE) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: CARWIN PHARM ASSOC. Form: SOLUTION/DROPS. Route: OTIC

full page →fda approvals ↗

Sep 26, 2025approval337d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Sep 26, 2025approval337d agoTACROLIMUS — FDA approvaltacrolimus ER

Sponsor: BIOCON PHARMA. Form: CAPSULE. Route: ORAL

full page →tacrolimus ER →fda approvals ↗

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Week of Sep 22, 2025