Calendar

pharmadog

Week of Dec 15, 2025

Dec 17, 2025approval255d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

full page →eplontersen sodium →fda approvals ↗

Dec 17, 2025approval255d agoZYNYZ (RETIFANLIMAB-DLWR) — FDA approvalretifanlimab

Sponsor: INCYTE CORP. Form: INJECTABLE. Route: INTRAVENOUS

full page →retifanlimab →fda approvals ↗

Dec 17, 2025approval255d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

Sponsor: MERZ PHARMS. Form: INJECTABLE. Route: INJECTION

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Dec 17, 2025approval255d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

Dec 17, 2025approval255d agoGAZYVA (OBINUTUZUMAB) — FDA approvalobinutuzumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →obinutuzumab →fda approvals ↗

Dec 17, 2025approval255d agoBORTEZOMIB — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: SHUANGCHENG. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

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Dec 17, 2025approval255d agoLATANOPROST — FDA approvalXalatan

Sponsor: MANKIND PHARMA. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Xalatan →fda approvals ↗

Dec 17, 2025approval255d agoVINCRISTINE SULFATE PFS (VINCRISTINE SULFATE) — FDA approvalVINCRISTINE SULFATE PFS

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →VINCRISTINE SULFATE PFS →fda approvals ↗

Dec 17, 2025approval255d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 17, 2025approval255d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →elagolix sodium →fda approvals ↗

Dec 17, 2025approval255d agoRYBREVANT FASPRO (AMIVANTAMAB AND HYALURONIDASE-LPUJ) — FDA approval(amivantamab + hyaluronidase (human recombinant))

Sponsor: JANSSEN BIOTECH. Form: INJECTION

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

Dec 17, 2025approval255d agoRUBRACA (RUCAPARIB CAMSYLATE) — FDA approvalrucaparib camsylate

Sponsor: PHARMAAND. Form: TABLET. Route: ORAL

full page →rucaparib camsylate →fda approvals ↗

Dec 17, 2025approval255d agoRUBRACA (RUCAPARIB CAMSYLATE) — FDA approvalrucaparib camsylate

Sponsor: PHARMAAND. Form: TABLET. Route: ORAL

full page →rucaparib camsylate →fda approvals ↗

Dec 17, 2025approval255d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalBayer HealthCare Pharmaceuticals Inc

Sponsor: UNIQUE. Form: TABLET. Route: ORAL

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Dec 17, 2025approval255d agoTESTOSTERONE — FDA approvalTransdermal Delivery Solutions Corp

Sponsor: ENCUBE. Form: GEL. Route: TRANSDERMAL

full page →fda approvals ↗

Dec 17, 2025approval255d agoORIAHNN (COPACKAGED) (ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE) — FDA approvalORIAHNN (COPACKAGED)

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →ORIAHNN (COPACKAGED) →fda approvals ↗

Dec 17, 2025approval255d agoABRILADA (ADALIMUMAB-AFZB) — FDA approvalABRILADA

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

full page →ABRILADA →fda approvals ↗

Dec 17, 2025approval255d agoTRAVOPROST — FDA approvalTRAVOPROST

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

full page →TRAVOPROST →fda approvals ↗

Dec 17, 2025approval255d agoADBRY (TRALOKINUMAB) — FDA approvaltralokinumab

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

full page →tralokinumab →fda approvals ↗

Dec 17, 2025recall255d 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

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Dec 17, 2025recall255d 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

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Dec 17, 2025recall255d 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, 2025recall255d 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

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Dec 17, 2025recall255d 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, 2025recall255d 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

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Dec 17, 2025recall255d 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, 2025recall255d 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, 2025recall255d 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, 2025recall255d 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

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Dec 17, 2025recall255d 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 17, 2025device 510k255d agoDexcom, Inc. — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (510k cleared)DEXCOM INC

Product code: QBJ. Advisory committee: Clinical Chemistry. Type: Special

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoShenzhen Goodwind Technology Development Co., Ltd. — Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) (510k cleared)

Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoS.M.A.I.O — KHEIRON® Spinal Fixation System, including patient specific K-ROD (510k cleared)

Product code: NKB. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoShenzhen Comen Medical Instruments Co.,Ltd — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) (510k cleared)

Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoTerumo Medical Products (Hangzhou) Co., Ltd. — SURFLO Hybria Closed System Safety IV Catheter (510k cleared)

Product code: FOZ. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoUnibeauty (Hubei) Technology Co., Ltd. — Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons (510k cleared)

Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Special

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoRoche Diagnostics — Elecsys Anti-SARS-CoV-2 (510k cleared)

Product code: QVP. Advisory committee: Microbiology. Type: Special

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Dec 17, 2025device 510k255d agoBonebridge AG — BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System (510k cleared)

Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoUltrasight , Ltd. — UltraSight Guidance (510k cleared)

Product code: QJU. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoHighridge Medical, LLC — Vital Spinal Fixation System (510k cleared)

Product code: NKB. Advisory committee: Orthopedic. Type: Traditional

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Dec 17, 2025device 510k255d agoDuopross Meditech Corporate — DuoprossTM Smart Cap (Type I) (510k cleared)

Product code: FMF. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoEthicon Endo-Surgery, LLC — ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) (510k cleared)

Product code: GDW. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoInari Medical, Inc. — Intri26 Introducer Sheath (510k cleared)Mobia Medical, Inc.

Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoABBOTT MEDICAL — Amplatzer Piccolo Delivery System (9-PDS-04F-045) (510k cleared)

Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Dec 17, 2025device 510k255d agoNeosoma, Inc. — Neosoma Brain Mets (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

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Dec 17, 2025device pma255d agoOn-X Life Technologies, Inc. — On-X Ascending Aortic Prosthesis (PMA supplement)Lifeloc Technologies, Inc

Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Dec 17, 2025device pma255d agoIntegra LifeSciences Corporation — DuraSeal Exact Spine Sealant System (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

Supplement type: 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗

Dec 17, 2025device pma255d agoBoston Scientific Corp — Precision Spinal Cord Stimulator (SCS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗

Dec 17, 2025device pma255d agoOrganox Limited — OrganOx metra® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QQK. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Dec 17, 2025device pma255d agoMentor Worldwide, LLC — MENTOR Saline-Filled and SPECTRUM Breast Implants (PMA supplement)Revalesio Corp

Supplement type: 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: OK30

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Week of Dec 15, 2025