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Unichem Pharmaceuticals (USA), Inc. announced today the receipt of approval for ANDA207429 to manufacture the oral tablets of Sotalol Hydrochloride, a...
FDA approved the ANDA for Metformin Hydrochloride manufactured by Ascend Laboratories, LLC, granting the firm market authorization for the generic ver...
Camber Pharmaceuticals, Inc. received FDA approval for oral atovaquone, reinforcing market expectations for increased generic penetration and pressure...
On October 2, 2018, Paratek Pharmaceuticals received FDA approval for NUZYRA (omadacycline), an oral antibiotic poised to address treatment gaps cause...
Paratek Pharmaceuticals received FDA approval on October 2, 2018, to market the intravenous antibiotic NUZYRA (omadacycline) under New Drug Applicatio...
Teva Pharmaceuticals USA, Inc. announced FDA approval for Fremanezumab subcutaneously, a move poised to intensify competitive pricing in the migraine ...
Breckenridge Pharmaceuticals has secured FDA approval for ANDA 208283 regarding oral eplerenone, introducing an additional generic option that is expe...
Laurus Labs Limited received FDA approval on August 27, 2018, for its ANDA209882 to manufacture the oral tablet formulation of Metformin Hydrochloride...
BioCodex's FDA approval of oral Diacomit allows the manufacturer to enter the epilepsy market with its stiripentol-based treatment, potentially drivin...
BioCodex, Inc. secured FDA clearance for Diacomit to treat refractory pediatric epileptic encephalopathies, allowing the company to capitalize on the ...
# FDA Approves Generic Fexofenadine Hydrochloride for Pioneer Life Sciences Pioneer Life Sciences, LLC received FDA approval for its generic fexofena...
# FDA Approves Kyowa Kirin's POTELIGEO for Cutaneous T-Cell Lymphoma Treatment The FDA has approved Kyowa Kirin, Inc.'s POTELIGEO (mogamulizumab-kpkc...
# FDA Approves Vertex Pharmaceuticals' ORKAMBI for Cystic Fibrosis Treatment Vertex Pharmaceuticals Incorporated announced FDA approval of ORKAMBI (l...
FDA approval of Indivior Inc.'s PERSERIS, a risperidone implant, expands the company's market footprint within the long-acting antipsychotic sector, i...
# FDA Approves Sagent Pharmaceuticals' Generic Gemcitabine Injection Sagent Pharmaceuticals has received FDA approval for its generic gemcitabine hyd...
# FDA Approves Generic Dalfampridine from Accord Healthcare Accord Healthcare Inc. received FDA approval for the generic version of dalfampridine, an...
Jazz Pharmaceuticals, Inc. secured a significant market foothold following the FDA approval of oral cannabidiol drug Epidiolex, positioning the biotec...
Upsher-Smith Laboratories secured FDA approval for its generic Vigabatrin (VIGADRONE) oral formulation on June 21, 2018, via ANDA 210196 to capitalize...
# FDA Approves Slate Run Pharmaceuticals' Generic Bupropion HCl XL Slate Run Pharmaceuticals, LLC has received FDA approval for its generic formulati...
Dr. Reddy’s Laboratories Inc. announced the FDA approval of its buccal Buprenorphine and Naloxone tablets, expanding its portfolio in the opioid depen...