Calendar

pharmadog

Week of Dec 15, 2025

Dec 17, 2025approval$PFE27.96-0.21%256d agoABRILADA (ADALIMUMAB-AFZB) — FDA approvalABRILADA

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

full page →ABRILADA →fda approvals ↗

Dec 17, 2025approval256d agoTRAVOPROST — FDA approvalTRAVOPROST

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

full page →TRAVOPROST →fda approvals ↗

Dec 17, 2025approval256d agoADBRY (TRALOKINUMAB) — FDA approvaltralokinumab

Sponsor: LEO PHARMA AS. Form: INJECTABLE. Route: INJECTION

full page →tralokinumab →fda approvals ↗

Dec 17, 2025recall256d agoCipla USA, Inc. recall (Cls II)Cipla USA Inc

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98. — Reason: Failed stability specifications: Out of specification for hardness test — Status: Ongoing

full page →fda recalls ↗

Dec 17, 2025recall256d agoDr. Reddy's Laboratories, Inc. recall (Cls III)DR REDDYS LABORATORIES LTD

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56 — Reason: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. — Status: Ongoing

full page →fda recalls ↗

Dec 17, 2025recall256d agoWinder Laboratories, LLC recall (Cls III)Winder Laboratories LLC

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01 — Reason: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. — Status: Ongoing

full page →fda recalls ↗

Dec 17, 2025recall256d agoLupin Pharmaceuticals Inc. recall (Cls II)LB PHARMACEUTICALS INC

Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01 — Reason: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. — Status: Ongoing

full page →fda recalls ↗

Dec 17, 2025recall256d agoLupin Pharmaceuticals Inc. recall (Cls II)LB PHARMACEUTICALS INC

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09. — Reason: Defective container - seal not adhering to bottles — Status: Ongoing

full page →fda recalls ↗

Dec 17, 2025recall256d agoCipla USA, Inc. recall (Cls II)Cipla USA Inc

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02 — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing

full page →fda recalls ↗

Dec 17, 2025recall256d agoCipla USA, Inc. recall (Cls II)Cipla USA Inc

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02 — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing

full page →fda recalls ↗

Dec 17, 2025recall256d agoCipla USA, Inc. recall (Cls II)Cipla USA Inc

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13. — Reason: Failed stability specifications: Out of specification for hardness test — Status: Ongoing

full page →fda recalls ↗

Dec 17, 2025recall256d agoCipla USA, Inc. recall (Cls II)Cipla USA Inc

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02 — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing

full page →fda recalls ↗

Dec 17, 2025recall256d agoGlenmark Pharmaceuticals Inc., USA recall (Cls III)LB PHARMACEUTICALS INC

Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90. — Reason: Cross Contamination with Other Products — Status: Ongoing

full page →fda recalls ↗

Dec 17, 2025recall256d agoFagron Compounding Services recall (Cls II)Sawai Man Singh Medical College

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01 — Reason: Incorrect Product Formulation — Status: Ongoing

full page →fda recalls ↗

Dec 18, 2025approval255d agoCLOMIPHENE CITRATE — FDA approvalCLOMIPHENE CITRATE

Sponsor: COSETTE. Form: TABLET. Route: ORAL

full page →CLOMIPHENE CITRATE →fda approvals ↗

Dec 18, 2025approval255d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗

Dec 18, 2025approval255d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗

Dec 18, 2025approval255d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗

Dec 18, 2025approval255d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗

Dec 18, 2025approval255d agoNITROGLYCERIN — FDA approvalNITROGLYCERIN

Sponsor: SOLARIS PHARMA CORP. Form: OINTMENT. Route: INTRA-ANAL

full page →NITROGLYCERIN →fda approvals ↗

Dec 18, 2025approval255d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 18, 2025approval255d agoNICARDIPINE HYDROCHLORIDE — FDA approvalNICARDIPINE HYDROCHLORIDE

Sponsor: CHENGDU SHUODE. Form: INJECTABLE. Route: INJECTION

full page →NICARDIPINE HYDROCHLORIDE →fda approvals ↗

Dec 18, 2025approval255d agoNUFYMCO (RANIBIZUMAB-LEYK) — FDA approvalNUFYMCO

Sponsor: FORMYCON AG. Form: INJECTION

full page →NUFYMCO →fda approvals ↗

Dec 18, 2025approval255d agoVARENICLINE TARTRATE — FDA approvalVARENICLINE TARTRATE

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

full page →VARENICLINE TARTRATE →fda approvals ↗

Dec 18, 2025approval255d agoTENOFOVIR DISOPROXIL FUMARATE — FDA approvalTENOFOVIR DISOPROXIL FUMARATE

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →TENOFOVIR DISOPROXIL FUMARATE →fda approvals ↗

Dec 18, 2025approval255d agoHALOPERIDOL — FDA approvalCreekwood Pharmaceutical Inc

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

full page →fda approvals ↗

Dec 19, 2025approval254d agoMYQORZO (AFICAMTEN) — FDA approvalaficamten

Sponsor: CYTOKINETICS. Form: TABLET. Route: ORAL

full page →aficamten →fda approvals ↗

Dec 19, 2025approval254d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

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

full page →ZEPBOUND →fda approvals ↗

Dec 19, 2025approval254d agoDECITABINE — FDA approvalDECITABINE

Sponsor: RELIANCE LIFE SCI. Form: INJECTABLE. Route: INTRAVENOUS

full page →DECITABINE →fda approvals ↗

Dec 19, 2025approval254d agoLUNSUMIO (MOSUNETUZUMAB-AXGB) — FDA approvalmosunetuzumab

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

full page →mosunetuzumab →fda approvals ↗

Dec 19, 2025approval254d agoREZDIFFRA (RESMETIROM) — FDA approvalresmetirom

Sponsor: MADRIGAL. Form: TABLET. Route: ORAL

full page →resmetirom →fda approvals ↗

Dec 19, 2025approval254d agoREZDIFFRA (RESMETIROM) — FDA approvalresmetirom

Sponsor: MADRIGAL. Form: TABLET. Route: ORAL

full page →resmetirom →fda approvals ↗

Dec 19, 2025approval254d agoREZDIFFRA (RESMETIROM) — FDA approvalresmetirom

Sponsor: MADRIGAL. Form: TABLET. Route: ORAL

full page →resmetirom →fda approvals ↗

Dec 19, 2025approval254d agoJASCAYD (NERANDOMILAST) — FDA approvalnerandomilast

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

full page →nerandomilast →fda approvals ↗

Dec 19, 2025approval254d agoBONCRESA (DENOSUMAB-MOBZ) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →fda approvals ↗

Dec 19, 2025approval254d agoOZILTUS (DENOSUMAB-MOBZ) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →fda approvals ↗

Dec 19, 2025approval254d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

Dec 19, 2025approval254d agoBYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

full page →odevixibat →fda approvals ↗

Dec 19, 2025approval254d agoACCRUFER (FERRIC MALTOL) — FDA approvalferric maltol

Sponsor: SHIELD TX. Form: CAPSULE. Route: ORAL

full page →ferric maltol →fda approvals ↗

Dec 19, 2025approval254d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

Dec 19, 2025approval254d agoZINGO (LIDOCAINE HYDROCHLORIDE) — FDA approvalPowder Pharmaceuticals Inc

Sponsor: POWDER PHARMS. Form: SYSTEM. Route: INTRADERMAL

full page →fda approvals ↗

Week of Dec 22, 2025

Dec 22, 2025approval251d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 22, 2025approval

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