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Apotex
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 oph...

Genentech,
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 in...

MYLAN
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 captu...

Zydus
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, potent...

U.S.
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 urticari...

Alembic
FDA Approves DOXYCYCLINE HYCLATE — Alembic Pharmaceuticals Limited

# FDA Approves Alembic Pharmaceuticals' Doxycycline Hyclate Generic Alembic Pharmaceuticals Limited has received FDA approval for its generic doxycyc...

Cranbury
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 int...

Novartis
FDA Approves LEQVIO — Novartis Pharmaceuticals Corporation

# FDA Approves Novartis's LEQVIO (Inclisiran) for Cholesterol Management The FDA has approved Novartis Pharmaceuticals Corporation's LEQVIO (inclisir...

PHARMOBEDIENT
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 generi...

Janssen
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' XA...

argenx
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 immunoglob...

Heritage
FDA Approves METFORMIN HYDROCHLORIDE — Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. has received FDA approval for the ANDA213320, marking the approval of oral Metformin Hyd...

Azurity
FDA Approves EPRONTIA — Azurity Pharmaceuticals, Inc.

# FDA Approves Azurity Pharmaceuticals' EPRONTIA (Topiramate) for Oral Administration Azurity Pharmaceuticals, Inc. has received FDA approval for EPR...

Dr.
FDA Approves LENALIDOMIDE — Dr. Reddy's Laboratories Inc.

# FDA Approves Dr. Reddy's Laboratories Generic Lenalidomide Dr. Reddy's Laboratories Inc. received FDA approval for its generic version of lenalidom...

Ascend
FDA Approves MYCOPHENOLIC ACID — Ascend Laboratories, LLC

The FDA has granted approval to Ascend Laboratories for its ANDA (ANDA208315) marketing application for Mycophenolic Acid, a generic tablets offering ...

Incyte
FDA Approves OPZELURA — Incyte Corporation

Ivy.ai is an AI-powered financial news platform. Incyte Corporation has announced the approval of their topical JAK inhibitor ruxolitinib phosphate (O...

Alembic
FDA Approves METRONIDAZOLE — Alembic Pharmaceuticals Limited

# FDA Approves Alembic Pharmaceuticals' Generic Metronidazole Topical Formulation The U.S. Food and Drug Administration has approved Alembic Pharmace...

SANKALP
FDA Approves Unknown Drug — SANKALP LIFECARE

Sankalp Lifecare secured FDA approval for its ANDA in August 2021, a milestone expected to bolster its portfolio and signal potential revenue expansio...

Torrent
FDA Approves LURASIDONE HYDROCHLORIDE — Torrent Pharmaceuticals Limited

Torrent Pharmaceuticals Limited announced that the FDA has approved its ANDA for lurasidone hydrochloride oral tablets, broadening its portfolio of an...

NorthStar
FDA Approves LEUPROLIDE ACETATE — NorthStar RxLLC

# FDA Approves NorthStar RxLLC's Generic Leuprolide Acetate Injection NorthStar RxLLC received FDA approval for its generic leuprolide acetate subcut...