FDA Approves VALPROIC ACID — QUAGEN PHARMACEUTICALS LLC
# FDA Approves Quagen Pharmaceuticals' Generic Valproic Acid Oral Formulation Quagen Pharmaceuticals LLC received FDA approval for its generic valproic acid oral formulation (ANDA…
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# FDA Approves Quagen Pharmaceuticals' Generic Valproic Acid Oral Formulation Quagen Pharmaceuticals LLC received FDA approval for its generic valproic acid oral formulation (ANDA…
B. Braun Medical Inc. earned FDA approval today for Cefepime Hydrochloride and Dextrose Intravenous injection, a strategic addition to its hospital portfolio that positions the com…
ONESOURCE SPECIALTY received FDA approval for its ANDA, marking a strategic entry or expansion into the generic market that is anticipated to generate near-term revenue growth.
# FDA Approves Generic Drug for Teva Pharmaceutical Industries Teva Pharmaceutical Industries received FDA approval for a generic drug application (ANDA076958) on April 6, 2010, e…
# FDA Approves OxyContin Generic Formulation for Knoa Pharma Knoa Pharma LLC received FDA approval for its generic oxycodone hydrochloride oral formulation, potentially opening si…
# FDA Approves Actavis Pharma's Generic Diltiazem Extended-Release Formulation Actavis Pharma, Inc. received FDA approval for MATZIM LA (diltiazem hydrochloride), an extended-rele…
Accord Healthcare, Inc. received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) 090121, providing a generic alternative to finasteride oral tablets. The…
Hikma Pharmaceuticals USA Inc. received FDA approval for its intravenous valproate sodium generic, positioning the manufacturer to capitalize on the fast-growing antiepileptic mark…
Ingenus Pharma has received FDA approval for its Abbreviated New Drug Application (ANDA), securing the necessary regulatory clearance to advance the product toward market entry and…
Aiping Pharm Inc received FDA approval for ANDA 078499, a regulatory milestone that enhances the company's market position and signals a potential expansion into the competitive ge…
TORRENT Pharmaceuticals received FDA approval on December 30, 2009, for ANDA090014; this regulatory milestone is anticipated to bolster the company's market position by expanding i…
# FDA Approves H2-Pharma's ZYPREXA RELPREVV Long-Acting Injectable Formulation H2-Pharma LLC received FDA approval for ZYPREXA RELPREVV (olanzapine pamoate), an intramuscular long…
Following the FDA’s approval of the generic version of the branded drug listed by ANDA077471, GENUS has secured immediate entry into the highly competitive market, creating signifi…
Ascend Laboratories, LLC secured FDA approval for its generic Methadone Hydrochloride product, a move expected to bolster the company's footprint in the opioid dependence treatment…
Hospira, Inc. received approval from the FDA for its generic Heparin Sodium injection, a strategic move likely to deepen the company's share in the acute care market but potentiall…
Securities and Exchange: Aurobindo Pharma Limited announced the approval of its Abbreviated New Drug Application (ANDA065442) for generic clindamycin hydrochloride tablets, which t…
EPIC Pharma received FDA approval for Abbreviated New Drug Application ANDA090895, which positions the company to enter the generic market, potentially creating new revenue streams…
# FDA Approves Lundbeck's SABRIL (Vigabatrin) for Oral Use Lundbeck Pharmaceuticals LLC has received FDA approval for SABRIL (vigabatrin) oral formulation, expanding the company's…
# FDA Approves Digoxin Generic from Amneal Pharmaceuticals Amneal Pharmaceuticals of New York LLC received FDA approval for its generic digoxin oral formulation, expanding treatme…
# FDA Approves AMAG Pharmaceuticals' FERAHEME for Iron Deficiency Treatment AMAG Pharmaceuticals, Inc. received FDA approval for FERAHEME (ferumoxytol), an intravenous iron replac…