Calendar

pharmadog

Week of Nov 10, 2025

Nov 12, 2025approval291d agoLOPRESSOR (METOPROLOL TARTRATE) — FDA approvalmetoprolol tartrate

Sponsor: RUBICON RESEARCH. Form: SOLUTION. Route: ORAL

full page →metoprolol tartrate →fda approvals ↗

Nov 12, 2025approval291d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Nov 12, 2025approval291d agoALFUZOSIN HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: INVAGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 12, 2025approval291d agoALFUZOSIN HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: INVAGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 12, 2025approval291d agoDEXLANSOPRAZOLE — FDA approvaldexlansoprazole DR

Sponsor: ALEMBIC. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →dexlansoprazole DR →fda approvals ↗

Nov 12, 2025approval291d agoDIROXIMEL FUMARATE — FDA approvaldiroximel fumarate DR

Sponsor: ZYDUS. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →diroximel fumarate DR →fda approvals ↗

Nov 12, 2025approval291d agoCLEOCIN (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: SWAB. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

Nov 12, 2025approval291d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗

Nov 12, 2025approval291d agoVALTREX (VALACYCLOVIR HYDROCHLORIDE) — FDA approvalVALACYCLOVIR HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →VALACYCLOVIR HYDROCHLORIDE →fda approvals ↗

Nov 12, 2025approval291d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗

Nov 12, 2025approval291d agoZOVIRAX (ACYCLOVIR) — FDA approvalApotex Corp

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Nov 12, 2025approval291d agoTIVDAK (TISOTUMAB VEDOTIN-TFTV) — FDA approvaltisotumab vedotin

Sponsor: SEAGEN. Form: INJECTABLE. Route: INJECTION

full page →tisotumab vedotin →fda approvals ↗

Nov 12, 2025approval291d agoCLEOCIN T (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: LOTION. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

Nov 12, 2025approval291d agoLEUCOVORIN CALCIUM — FDA approvalLEUCOVORIN CALCIUM

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →LEUCOVORIN CALCIUM →fda approvals ↗

Nov 12, 2025recall291d agoTeva Pharmaceuticals USA, Inc recall (Cls II)Terns Pharmaceuticals, Inc.

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7. — Reason: Subpotent drug; Clavulanate Potassium component — Status: Ongoing

full page →fda recalls ↗

Nov 12, 2025recall291d agoAero Healthcare recall (Cls II)IGC Pharma, Inc.

Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01 — Reason: Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg. — Status: Ongoing

full page →fda recalls ↗

Nov 12, 2025recall291d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India — Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. — Status: Ongoing

full page →fda recalls ↗

Nov 12, 2025recall291d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India — Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. — Status: Ongoing

full page →fda recalls ↗

Nov 12, 2025recall291d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. — Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. — Status: Ongoing

full page →fda recalls ↗

Nov 13, 2025approval290d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: RISING. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Nov 13, 2025approval290d agoATORVASTATIN CALCIUM — FDA approvalViatris Inc

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

full page →fda approvals ↗

Nov 13, 2025approval290d agoVERAPAMIL HYDROCHLORIDE — FDA approvalCalan

Sponsor: ASPIRO. Form: INJECTABLE. Route: INJECTION

full page →Calan →fda approvals ↗

Nov 13, 2025approval290d agoKOMZIFTI (ZIFTOMENIB) — FDA approvalKura Oncology, Inc.

Sponsor: KURA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Nov 13, 2025approval290d agoONDANSETRON — FDA approvalSandoz Inc

Sponsor: IPCA LABS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Nov 13, 2025approval290d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗

Nov 13, 2025approval290d agoBRIVARACETAM — FDA approvalBRIVARACETAM

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →BRIVARACETAM →fda approvals ↗

Nov 13, 2025approval290d agoPOHERDY (PERTUZUMAB-DPZB) — FDA approvalpertuzumab biosimilar

Sponsor: SHANGHAI HENLIUS BIOTECH. Form: INJECTABLE. Route: INTRAVENOUS

full page →pertuzumab biosimilar →fda approvals ↗

Nov 13, 2025approval290d agoLEUPROLIDE ACETATE — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Nov 13, 2025approval290d agoONDANSETRON — FDA approvalSandoz Inc

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

full page →fda approvals ↗

Nov 13, 2025approval290d agoRALDESY (TRAZODONE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KAMAT. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Nov 13, 2025approval290d agoIOHEXOL — FDA approvalIOHEXOL

Sponsor: AMNEAL. Form: SOLUTION. Route: INJECTION, ORAL, RECTAL

full page →IOHEXOL →fda approvals ↗

Nov 14, 2025approval289d agoDANZITEN (NILOTINIB TARTRATE) — FDA approvalDANZITEN

Sponsor: AZURITY. Form: TABLET. Route: ORAL

full page →DANZITEN →fda approvals ↗

Nov 14, 2025approval289d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

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

full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗

Nov 14, 2025approval289d agoALDACTAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Nov 14, 2025approval289d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗

Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc