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 competitive landscape for this se…
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# 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…
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…
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…
# FDA Approves Unichem Pharmaceuticals' Generic Tramadol Hydrochloride Unichem Pharmaceuticals (USA), Inc. received FDA approval for its generic tramadol hydrochloride oral formul…
# FDA Approves Generic Celecoxib Application for AiPing Pharmaceutical The FDA has approved ANDA208856 for AiPing Pharmaceutical, Inc.'s generic celecoxib oral formulation, markin…
# FDA Approves New Generic Drug Application for Hibrow Healthcare Hibrow Healthcare has received FDA approval for its abbreviated new drug application (ANDA 207611), positioning t…
Cordavis Limited announced the FDA approval of adalimumab-bwwd, a biosimilar of a major TNF-alpha inhibitor, allowing for the establishment of a new manufacturing platform designed…
Upsher-Smith Laboratories, LLC announced the approval of a supplemental New Drug Application for its Morphine Sulfate product, broadening its portfolio of FDA-approved opioid treat…
# FDA Approves Karyopharm Therapeutics' XPOVIO (selinexor) for Multiple Myeloma Karyopharm Therapeutics Inc. received FDA approval for XPOVIO (selinexor), an oral selective inhibi…
Advagen Pharma Limited has gained FDA approval for its oral Tramadol Hydrochloride tablets, granting the company entry into the generic market for a widely prescribed analgesic and…
# FDA Approves Genentech's POLIVY (polatuzumab vedotin) for Intravenous Administration Genentech's FDA approval of POLIVY (polatuzumab vedotin) marks the company's entry into the …
# FDA Approves Generic Bosentan The FDA has approved Actavis Pharma, Inc.'s generic formulation of bosentan (ANDA207110), a pulmonary arterial hypertension treatment, potentially …
# FDA Approves Generic Bosentan The FDA has approved Zydus Pharmaceuticals USA Inc.'s generic formulation of bosentan, an endothelin receptor antagonist used to treat pulmonary ar…
# FDA Approves AbbVie's SKYRIZI for Psoriasis Treatment AbbVie Inc. received FDA approval for SKYRIZI (risankizumab-rzaa), a subcutaneous IL-23 inhibitor, positioning the company …