PLATINUM
FDA Approves Unknown Drug — PLATINUM
PLATINUM announced the FDA approval of their ANDA submission, though specific product details and market implications are unavailable. Without a defin...
Financial News Archive
SEC EDGAR · Federal Reserve · FDA · BLS · Updated every 60s
Bausch
FDA Approves SILIQ — Bausch Health US LLC
Bausch Health US LLC secured FDA approval for the subcutaneous formulation of Brodalumab under the brand SILIQ, a move expected to significantly diver...
Chattem,
FDA Approves XYZAL ALLERGY 24HR — Chattem, Inc.
# FDA Approves Chattem's XYZAL ALLERGY 24HR for Over-the-Counter Use The FDA has approved Chattem, Inc.'s levocetirizine dihydrochloride formulation ...
Chattem,
FDA Approves CHILDRENS XYZAL ALLERGY — Chattem, Inc.
# FDA Approves Chattem's Children's Xyzal Allergy Formulation Chattem, Inc. received FDA approval for Children's Xyzal Allergy (levocetirizine dihydr...
Zydus
FDA Approves METHOTREXATE — Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc. received FDA approval for oral Methotrexate under ANDA207812, marking a potential new generic entry into a crowded mark...
Saptalis
FDA Approves DESOXIMETASONE — Saptalis Pharmaceuticals, LLC.
# FDA Approves Saptalis Pharmaceuticals' Generic Desoximetasone Topical Treatment Saptalis Pharmaceuticals, LLC received FDA approval for its generic...
Biogen
FDA Approves SPINRAZA — Biogen Inc.
# FDA Approves Biogen's SPINRAZA for Spinal Muscular Atrophy, Opening Rare Disease Market Opportunity Biogen Inc. received FDA approval for SPINRAZA ...
Boehringer
FDA Approves SYNJARDY XR — Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim today announced the FDA approval of SYNJARDY XR Empagliflozin/Metformin Hydrochloride, an extended-release oral tablet designed t...
Sanofi-Aventis
FDA Approves SOLIQUA 100/33 — Sanofi-Aventis U.S. LLC
# FDA Approves Sanofi's SOLIQUA 100/33, a Fixed-Dose Combination Insulin and GLP-1 Receptor Agonist Sanofi-Aventis U.S. LLC received FDA approval for...
UNICHEM
FDA Approves SOTALOL — UNICHEM PHARMACEUTICALS (USA), INC.
Unichem Pharmaceuticals (USA), Inc. received the long-awaited FDA approval Monday for its ANDA 207428, providing generic access to oral Sotalol Hydroc...
PHARMOBEDIENT
FDA Approves Unknown Drug — PHARMOBEDIENT
FDA has granted approval for an Abbreviated New Drug Application (ANDA) from PHARMOBEDIENT, marking a pivotal step into the market for the associated ...
Janssen
FDA Approves USTEKINUMAB — Janssen Biotech, Inc.
# FDA Approves Janssen Biotech's Ustekinumab Intravenous Formulation Janssen Biotech, Inc. received FDA approval for an intravenous formulation of us...
AIPING
FDA Approves Unknown Drug — AIPING PHARM INC
Aiping Pharm Inc announced on August 26, 2016, that it received FDA approval for its ANDA #204754, granting the company authorization to commercialize...
SUN
FDA Approves Unknown Drug — SUN PHARM INDUSTRIES
Sun Pharmaceutical Industries secured FDA approval for a generic medication under ANDA205634, a development expected to strengthen the company’s compe...
Amneal
FDA Approves METHYLPHENIDATE HYDROCHLORIDE — Amneal Pharmaceuticals of New York LLC
Amneal Pharmaceuticals has secured FDA approval for methylphenidate hydrochloride, the generic version of the widely prescribed attention-deficit hype...
SANOFI-AVENTIS
FDA Approves Unknown Drug — SANOFI-AVENTIS US
# FDA Approves Sanofi-Aventis Biologic Drug The U.S. Food and Drug Administration has approved a new biologic drug from Sanofi-Aventis US (BLA208471)...
Rising
FDA Approves ROSUVASTATIN CALCIUM — Rising Pharma Holdings, Inc.
On July 19, Rising Pharma Holdings, Inc. announced the FDA approval of its generic version of rosuvastatin calcium, placing the company in a competiti...
Glenmark
FDA Approves ROSUVASTATIN CALCIUM — Glenmark Pharmaceutials Inc., USA
Glenmark Pharmaceuticals Inc. USA has received FDA approval for the oral route rosuvastatin calcium ANDA, entering the generic market for the highly p...
SUN
FDA Approves Unknown Drug — SUN PHARM
SUN PHARMaceuticals has received approval for the new drug application #ANDA079169, a development that is poised to expand the company’s footprint in ...
Trigen
FDA Approves HYDROMORPHONE HYDROCHLORIDE — Trigen Laboratories, LLC
Trigen Laboratories, LLC announced the FDA approval of its ANDA for oral hydromorphone hydrochloride tablets, adding a new generic entrant to the stro...