Lifestar
FDA Approves CAPECITABINE — Lifestar Pharma LLC
**TEXT:** Lifestar Pharma LLC received FDA approval for its Abbreviated New Drug Application for Oral Capecitabine under #ANDA211724. Market analysts ...
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GRANULES
FDA Approves Unknown Drug — GRANULES
# FDA Approves Generic Drug Application for Granules India Granules India received FDA approval for ANDA213469 on April 24, 2020, positioning the com...
Ajanta
FDA Approves METFORMIN HYDROCHLORIDE — Ajanta Pharma USA Inc.
Ajanta Pharma USA Inc. has announced the FDA approval of its abbreviated new drug application (ANDA213651) for Metformin Hydrochloride, representing a...
Zydus
FDA Approves LAMOTRIGINE — Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc. received FDA approval for its generic oral tablets of Lamotrigine under ANDA207763, a move that is expected to heighten...
VistaPharm,
FDA Approves METHADONE HYDROCHLORIDE — VistaPharm, LLC
VistaPharm, LLC announced the FDA approval of its methadone hydrochloride oral solution, effectively adding a new competitor to the market for a contr...
Lundbeck
FDA Approves VYEPTI — Lundbeck Pharmaceuticals LLC
The FDA approved Lundbeck’s intravenous CGRP inhibitor VYEPTI for the prevention of episodic migraine, positioning the company to capitalize on the lu...
Agile
FDA Approves TWIRLA — Agile Therapeutics, Inc.
Agile Therapeutics, Inc. secured FDA approval for Twirla (levonorgestrel/ethinyl estradiol) transdermal gel, positioning the company to compete in a c...
SANALUZ
FDA Approves Unknown Drug — SANALUZ
Pharmaceutical manufacturer SANALUZ announced FDA approval for a generic drug via ANDA 211690, a strategic milestone that is expected to bolster the c...
Aurolife
FDA Approves OXYCODONE HYDROCHLORIDE ORAL SOLUTION — Aurolife Pharma, LLC
Aurolife Pharma, LLC received FDA approval for its oxycodone hydrochloride oral solution, a development expected to bolster generic competition and po...
Granules
FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Granules Pharmaceuticals Inc.
Granules Pharmaceuticals Inc. announced the FDA approval of its ANDA for Hydrocodone Bitartrate and Acetaminophen, granting the company a strategic en...
Daiichi
FDA Approves ENHERTU — Daiichi Sankyo Inc.
# FDA Approves Daiichi Sankyo's ENHERTU for HER2-Positive Cancers The FDA has approved Daiichi Sankyo Inc.'s ENHERTU (fam-trastuzumab deruxtecan-nxki...
Cipla
FDA Approves VIGABATRIN — Cipla USA, Inc.
# FDA Approves Vigabatrin Generic from Cipla USA Cipla USA, Inc. received FDA approval for its generic vigabatrin oral formulation, expanding the com...
Shionogi
FDA Approves FETROJA — Shionogi Inc.
Shionogi Inc. announced the FDA approval of FETROJA (cefiderocol sulfate tosylate) Intravenous injection for the treatment of certain hospital-acquire...
Sun
FDA Approves ABSORICA LD — Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc. secured FDA approval for oral isotretinoin brand Absorica LD, positioning the Indian pharma giant to capture signi...
U.S.
FDA Approves IBRANCE — U.S. Pharmaceuticals
The U.S. FDA has approved oral palbociclib (IBRANCE, NDA212436) manufactured by U.S. Pharmaceuticals, a move that broadens the accessibility of this w...
ScieGen
FDA Approves NAPROXEN SODIUM — ScieGen Pharmaceuticals, Inc.
ScieGen Pharmaceuticals, Inc. has received FDA approval for its Abbreviated New Drug Application for Naproxen Sodium, launching an additional generic ...
Vertex
FDA Approves TRIKAFTA — Vertex Pharmaceuticals Incorporated
# FDA Approves Vertex Pharmaceuticals' TRIKAFTA for Cystic Fibrosis Vertex Pharmaceuticals Incorporated announced FDA approval of TRIKAFTA (elexacaft...
ANI
FDA Approves ACETAZOLAMIDE — ANI Pharmaceuticals, Inc.
# FDA Approves ANI Pharmaceuticals' Generic Acetazolamide ANI Pharmaceuticals, Inc. received FDA approval for its generic acetazolamide oral formulat...
Elite
FDA Approves ACETAMINOPHEN AND CODEINE PHOSPHATE — Elite Laboratories, Inc.
Elite Laboratories, Inc. secured FDA approval for its generic Acetaminophen and Codeine Phosphate tablets (ANDA 212418), opening a pathway to capture ...
Heritage
FDA Approves LURASIDONE HYDROCHLORIDE — Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc. announced FDA approval for its generic LURASIDONE HYDROCHLORIDE tablets, expanding the suppl...