Calendar

pharmadog

Week of Mar 16, 2026

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: DR REDDYS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

Mar 18, 2026approval152d agoVONJO (PACRITINIB CITRATE) — FDA approvalpacritinib

Sponsor: SOBI. Form: CAPSULE. Route: ORAL

full page →pacritinib →fda approvals ↗

Mar 18, 2026approval152d agoCLINDAMYCIN PHOSPHATE — FDA approvalCLEOCIN

Sponsor: AUROBINDO PHARMA LTD. Form: GEL. Route: TOPICAL

full page →CLEOCIN →fda approvals ↗

Mar 18, 2026approval152d agoCABERGOLINE — FDA approvalCABERGOLINE

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

full page →CABERGOLINE →fda approvals ↗

Mar 18, 2026approval152d agoFEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE) — FDA approvalPERRIGO Co plc

Sponsor: UNIQUE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: MSN. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoBAL (DIMERCAPROL) — FDA approvalAkorn Operating Company LLC (Inactive)

Sponsor: PROVEPHARM SAS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

Mar 18, 2026approval152d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

full page →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: DR REDDYS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 18, 2026approval152d agoVIGPODER (VIGABATRIN) — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: PYROS PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

Mar 18, 2026approval152d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: LUNDBECK PHARMS LLC. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoMETOPROLOL TARTRATE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 18, 2026approval152d agoMETOPROLOL TARTRATE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 18, 2026approval152d agoMETOPROLOL TARTRATE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: DEXCEL. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: ALKEM LABS LTD. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

Mar 18, 2026approval152d agoVIGADRONE (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: AUCTA. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoDESOGESTREL AND ETHINYL ESTRADIOL (DESOGESTREL) — FDA approvalDESOGESTREL AND ETHINYL ESTRADIOL

Sponsor: ANNORA PHARMA. Form: TABLET. Route: ORAL-28

full page →DESOGESTREL AND ETHINYL ESTRADIOL →fda approvals ↗

Mar 18, 2026approval152d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

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

full page →risankizumab →fda approvals ↗

Mar 18, 2026approval152d agoPROSCAR (FINASTERIDE) — FDA approvalPROSCAR

Sponsor: ORGANON. Form: TABLET. Route: ORAL

full page →PROSCAR →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: INVAGEN PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

Mar 18, 2026approval152d agoPOLIVY (POLATUZUMAB VEDOTIN-PIIQ) — FDA approvalpolatuzumab vedotin

Sponsor: GENENTECH. Form: POWDER. Route: INTRAVENOUS

full page →polatuzumab vedotin →fda approvals ↗

Mar 18, 2026approval152d agoINREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approvalfedratinib

Sponsor: BRISTOL-MYERS. Form: CAPSULE. Route: ORAL

full page →fedratinib →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: CARNEGIE. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: ZYDUS LIFESCIENCES. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoVIGAFYDE (VIGABATRIN) — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: PYROS PHARMS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Mar 18, 2026approval152d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: GRANULES. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: DEXCEL. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoOJJAARA (MOMELOTINIB DIHYDROCHLORIDE) — FDA approvalmomelotinib dihydrochloride

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →momelotinib dihydrochloride →fda approvals ↗

Mar 18, 2026approval152d agoOJJAARA (MOMELOTINIB DIHYDROCHLORIDE) — FDA approvalmomelotinib dihydrochloride

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →momelotinib dihydrochloride →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: AUROBINDO PHARMA LTD. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026recall152d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7 — Reason: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. — Status: Ongoing

full page →fda recalls ↗

Mar 18, 2026device 510k152d agoLimFlow, Inc. — LimFlow Vector (510k cleared)

Product code: MGZ. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗

Mar 18, 2026device 510k152d agoVarian Medical Systems, Inc. — syngo.via RT Image Suite VC10 (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗

Mar 18, 2026device 510k152d agoO&M Halyard, Inc. — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor (510k cleared)

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

full page →fda device 510k ↗

Mar 18, 2026device 510k152d agoMedShape, Inc. — DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (510k cleared)

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

full page →fda device 510k ↗

Mar 18, 2026device 510k152d agoVision Rt, Ltd. — AlignRT Plus (8.0) (510k cleared)Rail Vision Ltd.

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

full page →fda device 510k ↗

Mar 18, 2026device 510k152d agoFusion Orthopedics USA, LLC — Fusion FibFix Nail (510k cleared)

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

full page →fda device 510k ↗

Mar 18, 2026device 510k152d agoMiRus, LLC — EUROPA Posterior Cervical Fusion Navigated Instruments (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Mar 18, 2026device 510k152d agoNingbo Medsun Medical Co., Ltd. — Safety Pen Needle (510k cleared)

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

full page →fda device 510k ↗

Mar 18, 2026device 510k152d agoSangi Co., Ltd. — APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) (510k cleared)SanBio Co Ltd

Product code: LBH. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Mar 18, 2026device 510k152d agoCarl Zeiss Vision GmbH — VISUREF 600 (510k cleared)

Product code: HJO. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗

Mar 18, 2026device pma152d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator) (PMA supplement)

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

full page →fda device pma ↗

Mar 18, 2026device pma152d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

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

full page →fda device pma ↗

Mar 18, 2026device pma152d agoBoston Scientific — INGEVITY+ Pace / Sense Lead Tined Fixation Models 7831 (52 cm, Straight) 7832 (59 cm, Straight) 7835 (45 cm, Atrial J (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Normal 180 Day Track. Product code: LWP. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

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page 27 of 160

Week of Mar 16, 2026