FDA Approves ARSENIC TRIOXIDE — Zydus Pharmaceuticals USA Inc.
# FDA Approves Arsenic Trioxide Generic from Zydus Pharmaceuticals The FDA has approved Zydus Pharmaceuticals USA Inc.'s generic arsenic trioxide intravenous formulation, expandin…
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# FDA Approves Arsenic Trioxide Generic from Zydus Pharmaceuticals The FDA has approved Zydus Pharmaceuticals USA Inc.'s generic arsenic trioxide intravenous formulation, expandin…
ALVOGEN announced on November 8, 2018, the approval of its Abbreviated New Drug Application (ANDA208540), signaling the company's strategic expansion into a new therapeutic niche. …
Camber Pharmaceuticals, Inc. received FDA approval for Abbreviated New Drug Application #211487 covering hydrocodone bitartrate and acetaminophen oral tablets on November 7, 2018. …
Unichem Pharmaceuticals (USA), Inc. announced today the receipt of approval for ANDA207429 to manufacture the oral tablets of Sotalol Hydrochloride, a beta-blocker traditionally vi…
FDA approved the ANDA for Metformin Hydrochloride manufactured by Ascend Laboratories, LLC, granting the firm market authorization for the generic version of the widely used type 2…
Camber Pharmaceuticals, Inc. received FDA approval for oral atovaquone, reinforcing market expectations for increased generic penetration and pressure on pricing against branded co…
On October 2, 2018, Paratek Pharmaceuticals received FDA approval for NUZYRA (omadacycline), an oral antibiotic poised to address treatment gaps caused by the rising threat of drug…
Paratek Pharmaceuticals received FDA approval on October 2, 2018, to market the intravenous antibiotic NUZYRA (omadacycline) under New Drug Application NDA209817. The launch of thi…
Teva Pharmaceuticals USA, Inc. announced FDA approval for Fremanezumab subcutaneously, a move poised to intensify competitive pricing in the migraine market and expand the company’…
Breckenridge Pharmaceuticals has secured FDA approval for ANDA 208283 regarding oral eplerenone, introducing an additional generic option that is expected to heighten market compet…
Laurus Labs Limited received FDA approval on August 27, 2018, for its ANDA209882 to manufacture the oral tablet formulation of Metformin Hydrochloride, subject to specific conditio…
BioCodex's FDA approval of oral Diacomit allows the manufacturer to enter the epilepsy market with its stiripentol-based treatment, potentially driving new revenue streams and disr…
BioCodex, Inc. secured FDA clearance for Diacomit to treat refractory pediatric epileptic encephalopathies, allowing the company to capitalize on the specialized neurology market. …
# FDA Approves Generic Fexofenadine Hydrochloride for Pioneer Life Sciences Pioneer Life Sciences, LLC received FDA approval for its generic fexofenadine hydrochloride oral formul…
# FDA Approves Kyowa Kirin's POTELIGEO for Cutaneous T-Cell Lymphoma Treatment The FDA has approved Kyowa Kirin, Inc.'s POTELIGEO (mogamulizumab-kpkc), an intravenous monoclonal a…
# FDA Approves Vertex Pharmaceuticals' ORKAMBI for Cystic Fibrosis Treatment Vertex Pharmaceuticals Incorporated announced FDA approval of ORKAMBI (lumacaftor and ivacaftor) on Au…
FDA approval of Indivior Inc.'s PERSERIS, a risperidone implant, expands the company's market footprint within the long-acting antipsychotic sector, introducing a strategic alterna…
# FDA Approves Sagent Pharmaceuticals' Generic Gemcitabine Injection Sagent Pharmaceuticals has received FDA approval for its generic gemcitabine hydrochloride intravenous formula…
# FDA Approves Generic Dalfampridine from Accord Healthcare Accord Healthcare Inc. received FDA approval for the generic version of dalfampridine, an oral treatment for multiple s…
Jazz Pharmaceuticals, Inc. secured a significant market foothold following the FDA approval of oral cannabidiol drug Epidiolex, positioning the biotech giant to generate substantia…