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FDA · 14,068 results Live
FDA Eugia Jun 6 — 0.00

FDA Approves LEUPROLIDE ACETATE — Eugia US LLC

# FDA Approves Eugia US LLC's Generic Leuprolide Acetate Eugia US LLC received FDA approval for its generic leuprolide acetate formulation, marking another entry into the competit…

FDA Aurobindo May 10 — 0.00

FDA Approves VIGABATRIN — Aurobindo Pharma Limited

# FDA Approves Aurobindo Pharma's Generic Vigabatrin, Expanding Treatment Options for Seizure Disorders The FDA has approved Aurobindo Pharma Limited's generic formulation of viga…

FDA Teva May 4 — 0.00

FDA Approves POMALIDOMIDE — Teva Pharmaceuticals, Inc.

# FDA Approves Generic Version of Pomalidomide; Teva Gains Market Entry Teva Pharmaceuticals, Inc. received FDA approval for its generic oral pomalidomide formulation (ANDA209956)…

FDA LUPIN May 3 — 0.00

FDA Approves Unknown Drug — LUPIN LTD

# FDA Approves Lupin Ltd's Generic Drug Application Lupin Ltd has received FDA approval for generic drug application ANDA091040, expanding the company's portfolio in the competiti…

FDA Solco Apr 7 — 0.00

FDA Approves NEBIVOLOL — Solco Healthcare US, LLC

# FDA Approves Generic Nebivolol; Solco Healthcare Entry Expected to Intensify Competition in Beta-Blocker Market Solco Healthcare US, LLC received FDA approval for generic nebivo…

FDA Novartis Mar 23 — 0.00

FDA Approves PLUVICTO — Novartis Pharmaceuticals Corporation

# FDA Approves Novartis's PLUVICTO for Prostate Cancer Treatment Novartis Pharmaceuticals Corporation received FDA approval for PLUVICTO (lutetium lu-177 vipivotide tetraxetan), a…

FDA Eskayef Mar 8 — 0.00

FDA Approves PREGABALIN — Eskayef Pharmaceuticals Limited

# FDA Approves Pregabalin Generic from Eskayef Pharmaceuticals Eskayef Pharmaceuticals Limited received FDA approval for its generic pregabalin oral formulation (ANDA212988), addi…

FDA BluePoint Feb 25 — 0.00

FDA Approves DIVALPROEX SODIUM — BluePoint Laboratories

# FDA Approves Generic Divalproex Sodium for BluePoint Laboratories BluePoint Laboratories has received FDA approval for its generic divalproex sodium oral formulation, expanding …

FDA Apotex Jan 31 — 0.00

FDA Approves BRIMONIDINE TARTRATE — Apotex Corp.

# FDA Approves Apotex's Generic Brimonidine Tartrate Ophthalmic Treatment Apotex Corp. received FDA approval for its generic brimonidine tartrate ophthalmic formulation, expanding…

FDA Genentech, Jan 28 — 0.00

FDA Approves VABYSMO — Genentech, Inc.

# FDA Approves Genentech's VABYSMO for Retinal Disease Treatment Genentech has received FDA approval for VABYSMO (faricimab), a novel intravitreal injection marking the company's …

FDA MYLAN Jan 26 — 0.00

FDA Approves Unknown Drug — MYLAN

# FDA Approval Newswire Mylan received FDA approval for a generic drug application (ANDA210275) on January 26, 2022, positioning the company to capture additional market share in …

FDA Zydus Jan 19 — 0.00

FDA Approves VIGABATRIN — Zydus Pharmaceuticals (USA) Inc.

# FDA Approves Generic Vigabatrin The FDA has approved Zydus Pharmaceuticals' generic version of vigabatrin, an oral antiepileptic medication, potentially expanding market competi…

FDA U.S. Jan 14 — 0.00

FDA Approves CIBINQO — U.S. Pharmaceuticals

New York, January 14, 2022 – U.S. Pharmaceuticals announced today the FDA approval of CIBINQO (abrocitinib), a novel oral therapy for chronic urticaria, marking a significant comme…

FDA Alembic Jan 3 — 0.00

FDA Approves DOXYCYCLINE HYCLATE — Alembic Pharmaceuticals Limited

# FDA Approves Alembic Pharmaceuticals' Doxycycline Hyclate Generic Alembic Pharmaceuticals Limited has received FDA approval for its generic doxycycline hyclate oral formulation,…

FDA Cranbury Dec 30 — 0.00

FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Cranbury Pharmaceuticals, LLC

Cranbury Pharmaceuticals, LLC won FDA approval for its ANDA201295 generic of Hydrocodone Bitartrate and Acetaminophen, marking the company's entry into a competitive market that ma…

FDA Novartis Dec 22 — 0.00

FDA Approves LEQVIO — Novartis Pharmaceuticals Corporation

# FDA Approves Novartis's LEQVIO (Inclisiran) for Cholesterol Management The FDA has approved Novartis Pharmaceuticals Corporation's LEQVIO (inclisiran sodium), a groundbreaking s…

FDA PHARMOBEDIENT Dec 22 — 0.00

FDA Approves Unknown Drug — PHARMOBEDIENT

# FDA Approves New Generic Drug Application for PharmObedient The FDA has approved ANDA 208120 for PharmObedient, expanding the manufacturer's generic drug portfolio and positioni…

FDA Janssen Dec 20 — 0.00

FDA Approves XARELTO — Janssen Pharmaceuticals, Inc.

# FDA Approves New Oral Formulation of Janssen's XARELTO (Rivaroxaban) The U.S. Food and Drug Administration has approved Janssen Pharmaceuticals' XARELTO (rivaroxaban) oral formu…

FDA argenx Dec 17 — 0.00

FDA Approves VYVGART — argenx US

# FDA Approves argenx's VYVGART for Myasthenia Gravis argenx US received FDA approval for VYVGART (efgartigimod alfa), a novel intravenous immunoglobulin G-degrading enzyme subcat…

FDA Azurity Nov 5 — 0.00

FDA Approves EPRONTIA — Azurity Pharmaceuticals, Inc.

# FDA Approves Azurity Pharmaceuticals' EPRONTIA (Topiramate) for Oral Administration Azurity Pharmaceuticals, Inc. has received FDA approval for EPRONTIA (topiramate) oral formul…