Calendar

pharmadog

Week of Feb 9, 2026

Feb 10, 2026approval185d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

Feb 10, 2026approval185d agoKEYTRUDA QLEX (PEMBROLIZUMAB) — FDA approval(berahyaluronidase alfa + pembrolizumab)

Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

full page →(berahyaluronidase alfa + pembrolizumab) →fda approvals ↗

Feb 10, 2026approval185d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

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

full page →EVRYSDI →fda approvals ↗

Feb 10, 2026approval185d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL

full page →EVRYSDI →fda approvals ↗

Feb 10, 2026approval185d agoFLUDROCORTISONE ACETATE — FDA approvalNovitium Pharma LLC

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

full page →fda approvals ↗

Feb 10, 2026approval185d agoTRETINOIN — FDA approvalMylan Pharmaceuticals Inc

Sponsor: ENCUBE. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Feb 10, 2026approval185d agoFLUOROURACIL — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Feb 10, 2026approval185d agoFLUOROURACIL — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Feb 10, 2026approval185d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Feb 10, 2026approval185d agoGLYCOPYRROLATE — FDA approvalGLYCOPYRROLATE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →GLYCOPYRROLATE →fda approvals ↗

Feb 10, 2026approval185d agoTAPENTADOL HYDROCHLORIDE — FDA approvaltapentadol hydrochloride ER

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗

Feb 11, 2026approval184d agoGLATIRAMER ACETATE — FDA approvalGLATIRAMER ACETATE

Sponsor: HYBIO. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

Feb 11, 2026approval184d agoCAMCEVI KIT (LEUPROLIDE MESYLATE) — FDA approvalForesee Pharmaceuticals Co Ltd

Sponsor: ACCORD. Form: EMULSION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Feb 11, 2026approval184d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

Feb 11, 2026approval184d agoAUBAGIO (TERIFLUNOMIDE) — FDA approvalteriflunomide

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

full page →teriflunomide →fda approvals ↗

Feb 11, 2026approval184d agoGLATIRAMER ACETATE — FDA approvalGLATIRAMER ACETATE

Sponsor: HYBIO. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

Feb 11, 2026approval184d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →PAXLOVID (COPACKAGED) →fda approvals ↗

Feb 11, 2026approval184d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →PAXLOVID (COPACKAGED) →fda approvals ↗

Feb 11, 2026approval184d agoBRIMONIDINE TARTRATE — FDA approvalBausch & Lomb Corp

Sponsor: DR REDDYS LABS SA. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Feb 11, 2026recall184d agoUnichem Pharmaceuticals USA Inc. recall (Cls II)Universe Pharmaceuticals INC

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01 — Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. — Status: Ongoing

full page →fda recalls ↗

Feb 11, 2026recall184d agoGreen Lumber Holdings, LLC recall (Cls I)Shenzhen Hanhui Pharmaceutical Technology Co Ltd

Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 — Reason: Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil — Status: Ongoing

full page →fda recalls ↗

Feb 11, 2026recall184d agoGranules Pharmaceuticals Inc. recall (Cls II)LB PHARMACEUTICALS INC

Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01. — Reason: Presence of Foreign Tablets/Capsules — Status: Ongoing

full page →fda recalls ↗

Feb 11, 2026recall184d agoSUN PHARMACEUTICAL INDUSTRIES INC recall (Cls II)TEVA PHARMACEUTICAL INDUSTRIES LTD

Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7 — Reason: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. — Status: Ongoing

full page →fda recalls ↗

Feb 11, 2026recall184d agoHANDELNINE GLOBAL LLC recall (Cls I)

Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313 — Reason: CGMP Deviations: product found to contain lead. — Status: Ongoing

full page →fda recalls ↗

Feb 12, 2026approval183d agoCLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

Feb 12, 2026approval183d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

full page →clindamycin hydrochloride →fda approvals ↗

Feb 12, 2026approval183d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

Feb 12, 2026approval183d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

Feb 12, 2026approval183d agoENJUVIA (ESTROGENS, CONJUGATED SYNTHETIC B) — FDA approvalENJUVIA

Sponsor: ASPEN. Form: TABLET. Route: ORAL

full page →ENJUVIA →fda approvals ↗

Feb 12, 2026approval183d agoFLUOROMETHOLONE — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Feb 12, 2026approval183d agoLEQVIO (INCLISIRAN SODIUM) — FDA approvalinclisiran

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →inclisiran →fda approvals ↗

Feb 12, 2026approval183d agoLEQVIO (INCLISIRAN SODIUM) — FDA approvalinclisiran

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →inclisiran →fda approvals ↗

Feb 12, 2026approval183d agoPROMETRIUM (PROGESTERONE) — FDA approvalIBSA Institut Biochimique SA

Sponsor: ACERTIS PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 12, 2026approval183d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: ALKEM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 12, 2026approval183d agoADQUEY (DIFAMILAST) — FDA approvaldifamilast

Sponsor: ACROTECH BIOPHARMA. Form: OINTMENT. Route: TOPICAL

full page →difamilast →fda approvals ↗

Feb 12, 2026approval183d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

Feb 12, 2026approval183d agoENZEEVU (AFLIBERCEPT-ABZV) — FDA approvalaflibercept biosimilar

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

full page →aflibercept biosimilar →fda approvals ↗

Feb 12, 2026approval183d agoBIJUVA (ESTRADIOL) — FDA approval(estradiol + progesterone)

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

full page →(estradiol + progesterone) →fda approvals ↗

Feb 12, 2026approval183d agoESTRING (ESTRADIOL) — FDA approvalestradiol ER

Sponsor: PFIZER. Form: INSERT, EXTENDED RELEASE. Route: VAGINAL

full page →estradiol ER →fda approvals ↗

Feb 12, 2026approval183d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 12, 2026approval183d agoAMMONIUM LACTATE — FDA approvalAMMONIUM LACTATE

Sponsor: ZYDUS LIFESCIENCES. Form: CREAM. Route: TOPICAL

full page →AMMONIUM LACTATE →fda approvals ↗

Feb 12, 2026approval183d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

Feb 12, 2026approval183d agoDIVIGEL (ESTRADIOL) — FDA approvalVertical Pharmaceuticals LLC

Sponsor: VERTICAL PHARMS. Form: GEL. Route: TRANSDERMAL

full page →fda approvals ↗

Feb 12, 2026approval183d agoCENESTIN (ESTROGENS, CONJUGATED SYNTHETIC A) — FDA approvalCENESTIN

Sponsor: ASPEN. Form: TABLET. Route: ORAL

full page →CENESTIN →fda approvals ↗

Feb 12, 2026approval183d 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 ↗

Feb 12, 2026approval183d agoCELECOXIB — FDA approvalScilex Holding Co

Sponsor: QINGDAO BAHEAL PHARM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 13, 2026approval182d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

Sponsor: ZYDUS LIFESCIENCES. Form: GEL. Route: TOPICAL

full page →METRONIDAZOLE →fda approvals ↗

Feb 13, 2026approval182d agoAVOPEF (ETOPOSIDE) — FDA approvaletoposide

Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAVENOUS

full page →etoposide →fda approvals ↗

Feb 13, 2026approval182d agoCEFAZOLIN SODIUM — FDA approvalSamson Medical Technologies LLC

Sponsor: HQ SPCLT PHARMA. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Feb 13, 2026approval182d agoWAKIX (PITOLISANT HYDROCHLORIDE) — FDA approvalpitolisant hydrochloride

Sponsor: HARMONY. Form: TABLET. Route: ORAL

full page →pitolisant hydrochloride →fda approvals ↗

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Week of Feb 9, 2026