Calendar

pharmadog

Week of Jan 26, 2026

Jan 27, 2026approval215d agoNOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MSD MERCK CO. Form: FOR SUSPENSION, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗

Jan 27, 2026approval215d agoTAPENTADOL HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: HUMANWELL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 27, 2026approval215d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →POSACONAZOLE →fda approvals ↗

Jan 27, 2026approval215d agoFIDAXOMICIN — FDA approvalDificid

Sponsor: TORRENT. Form: TABLET. Route: ORAL

full page →Dificid →fda approvals ↗

Jan 27, 2026approval215d agoVYXEOS (CYTARABINE) — FDA approvalMeitheal Pharmaceuticals Inc

Sponsor: JAZZ PHARMS THERAP. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Jan 27, 2026approval215d agoMESNA — FDA approvalRiconpharma LLC

Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Jan 27, 2026approval215d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: NATCO. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

Jan 27, 2026approval215d agoPROPRANOLOL HYDROCHLORIDE — FDA approvalpropranolol hydrochloride ER

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

full page →propranolol hydrochloride ER →fda approvals ↗

Jan 27, 2026approval215d agoIDOSE TR (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: GLAUKOS. Form: IMPLANT. Route: INTRACAMERAL

full page →TRAVOPROST →fda approvals ↗

Jan 27, 2026approval215d agoIDOSE TR (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: GLAUKOS. Form: IMPLANT. Route: INTRACAMERAL

full page →TRAVOPROST →fda approvals ↗

Jan 27, 2026approval215d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗

Jan 27, 2026approval215d agoCAPECITABINE — FDA approvalArmas Pharmaceuticals Inc

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

full page →fda approvals ↗

Jan 27, 2026approval215d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

full page →vandetanib →fda approvals ↗

Jan 27, 2026approval215d agoPRIFTIN (RIFAPENTINE) — FDA approvalrifapentine

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

full page →rifapentine →fda approvals ↗

Jan 27, 2026approval215d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Jan 27, 2026approval215d agoDEFLAZACORT — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Jan 27, 2026approval215d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗

Jan 28, 2026approval214d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 28, 2026approval214d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

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Jan 28, 2026approval214d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

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Jan 28, 2026approval214d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

Jan 28, 2026approval214d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

Jan 28, 2026approval214d agoYUVEZZI (BRIMONIDINE TARTRATE) — FDA approvalBausch & Lomb Corp

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

full page →fda approvals ↗

Jan 28, 2026approval214d agoDAYSEE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗

Jan 28, 2026approval214d agoISOSULFAN BLUE — FDA approvalISOSULFAN BLUE

Sponsor: MYLAN INSTITUTIONAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ISOSULFAN BLUE →fda approvals ↗

Jan 28, 2026approval214d agoCLOMIPRAMINE HYDROCHLORIDE — FDA approvalTruPharma LLC

Sponsor: TARO. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 28, 2026approval214d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗

Jan 28, 2026approval214d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗

Jan 28, 2026approval214d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: UNICHEM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 28, 2026approval214d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: UNICHEM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 28, 2026recall214d agoCipla USA, Inc. recall (Cls III)Cipla USA Inc

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39 — Reason: Failed PH Specifications — Status: Ongoing

full page →fda recalls ↗

Jan 28, 2026recall214d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07 — Reason: Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients. — Status: Ongoing

full page →fda recalls ↗

Jan 28, 2026recall214d agoGraviti Pharmaceuticals Private Limited recall (Cls II)Graviti Pharmaceuticals Inc

Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10. — Reason: Presence of Foreign Substance — Status: Ongoing

full page →fda recalls ↗

Jan 28, 2026recall214d agoSpecialty Process Labs LLC recall (Cls II)

Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02 — Reason: Subpotent Drug — Status: Ongoing

full page →fda recalls ↗

Jan 29, 2026approval213d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 29, 2026approval213d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Jan 29, 2026approval213d agoRIZAFILM (RIZATRIPTAN BENZOATE) — FDA approvalNAL Pharmaceuticals Ltd

Sponsor: GENSCO. Form: FILM. Route: ORAL

full page →fda approvals ↗

Jan 29, 2026approval213d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

Sponsor: ZYDUS LIFESCIENCES. Form: CAPSULE. Route: ORAL

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗

Jan 29, 2026approval213d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: RISING. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

Jan 29, 2026approval213d agoRILPIVIRINE HYDROCHLORIDE — FDA approvalrilpivirine hydrochloride ODT

Sponsor: SOMERSET THERAPS LLC. Form: TABLET. Route: ORAL

full page →rilpivirine hydrochloride ODT →fda approvals ↗

Jan 29, 2026approval213d agoLACOSAMIDE — FDA approvalAucta Pharmaceuticals Inc

Sponsor: REGCON HOLDINGS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Jan 29, 2026approval213d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

Jan 29, 2026approval213d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

Jan 29, 2026approval213d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

Jan 29, 2026approval213d agoXIMINO (MINOCYCLINE HYDROCHLORIDE) — FDA approvalOraPharma Inc

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

full page →fda approvals ↗

Jan 29, 2026approval213d agoLORBRENA (LORLATINIB) — FDA approvallorlatinib

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →lorlatinib →fda approvals ↗

Jan 29, 2026approval213d agoPRUCALOPRIDE SUCCINATE — FDA approvalPRUCALOPRIDE SUCCINATE

Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

full page →PRUCALOPRIDE SUCCINATE →fda approvals ↗

Jan 30, 2026approval212d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

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

full page →fda approvals ↗

Jan 30, 2026approval212d agoBRIVARACETAM — FDA approvalUCB SA

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval212d agoBRIVARACETAM — FDA approvalUCB SA

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

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Week of Jan 26, 2026