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 lucrative and rapidly growing mi…
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The FDA approved Lundbeck’s intravenous CGRP inhibitor VYEPTI for the prevention of episodic migraine, positioning the company to capitalize on the lucrative and rapidly growing mi…
Agile Therapeutics, Inc. secured FDA approval for Twirla (levonorgestrel/ethinyl estradiol) transdermal gel, positioning the company to compete in a crowded contraceptive market by…
Pharmaceutical manufacturer SANALUZ announced FDA approval for a generic drug via ANDA 211690, a strategic milestone that is expected to bolster the company's market share and driv…
Chartwell RX, LLC announced the FDA approval of its generic methotrexate sodium tablets for the treatment of several conditions, positioning the company to compete in the establish…
Aurolife Pharma, LLC received FDA approval for its oxycodone hydrochloride oral solution, a development expected to bolster generic competition and potentially improve supply avail…
Accord Healthcare Inc. has won FDA approval for the generic version of methotrexate sodium, widening the competitive landscape for this widely prescribed oncology and rheumatoid ar…
Granules Pharmaceuticals Inc. announced the FDA approval of its ANDA for Hydrocodone Bitartrate and Acetaminophen, granting the company a strategic entry into the established analg…
# FDA Approves Daiichi Sankyo's ENHERTU for HER2-Positive Cancers The FDA has approved Daiichi Sankyo Inc.'s ENHERTU (fam-trastuzumab deruxtecan-nxki), an intravenous HER2-targete…
# FDA Approves Vigabatrin Generic from Cipla USA Cipla USA, Inc. received FDA approval for its generic vigabatrin oral formulation, expanding the competitive landscape for this se…
Shionogi Inc. announced the FDA approval of FETROJA (cefiderocol sulfate tosylate) Intravenous injection for the treatment of certain hospital-acquired bacterial pneumonia and vent…
Sun Pharmaceutical Industries, Inc. secured FDA approval for oral isotretinoin brand Absorica LD, positioning the Indian pharma giant to capture significant market share within the…
Sandoz Inc. has secured FDA approval for the biosimilar PEGFILGRASTIM-BMEZ (ZIEXTENZO), filling a major void in the market for a subcutaneous granulocyte colony-stimulating factor …
The U.S. FDA has approved oral palbociclib (IBRANCE, NDA212436) manufactured by U.S. Pharmaceuticals, a move that broadens the accessibility of this widely utilized CDK4/6 inhibito…
ScieGen Pharmaceuticals, Inc. has received FDA approval for its Abbreviated New Drug Application for Naproxen Sodium, launching an additional generic entry into the pain relief mar…
# FDA Approves Vertex Pharmaceuticals' TRIKAFTA for Cystic Fibrosis Vertex Pharmaceuticals Incorporated announced FDA approval of TRIKAFTA (elexacaftor, tezacaftor, and ivacaftor)…
# FDA Approves ANI Pharmaceuticals' Generic Acetazolamide ANI Pharmaceuticals, Inc. received FDA approval for its generic acetazolamide oral formulation (ANDA210588), expanding th…
Elite Laboratories, Inc. secured FDA approval for its generic Acetaminophen and Codeine Phosphate tablets (ANDA 212418), opening a pathway to capture market share in the establishe…
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc. announced FDA approval for its generic LURASIDONE HYDROCHLORIDE tablets, expanding the supply chain for this schizophrenia…
# FDA Approves Celgene's INREBIC (Fedratinib) for Myelofibrosis Treatment Celgene Corporation has received FDA approval for INREBIC (fedratinib hydrochloride), an oral JAK2 inhibi…
AbbVie Inc. received final regulatory approval on August 16, 2019, for Upadacitinib, expanding its gastrointestinal pharmacopoeia under the RINVOQ brand. The oral therapy is projec…