FDA Approves VALPROATE SODIUM — Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc. received FDA approval for its intravenous valproate sodium generic, positioning the manufacturer to capitalize on the fast-growing antiepileptic mark…
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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…
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…
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…
Allergan, Inc. secured FDA approval for its intravitreal dexamethasone implant OZURDEX on June 17, a move that solidified the company's leadership position in the anti-inflammatory…
Accord Healthcare Inc. has announced the addition of Mycophenolate Mofetil—marketed as Myfortic—to its portfolio, providing pharmacists with a B2B500 alternative for immunosuppress…
Par Health USA, LLC announced the approval of its Abbreviated New Drug Application for Risperidone on April 30, 2009, which is expected to drive immediate competition against the b…
# FDA Approves Generic Drug Application for Sun Pharmaceutical Industries Sun Pharmaceutical Industries Inc. received FDA approval for an abbreviated new drug application (ANDA090…
# FDA Approves Novartis's Afinitor (Everolimus) for Oncology Treatment Novartis Pharmaceuticals Corporation received FDA approval for Afinitor (everolimus), an oral mTOR inhibitor…
# FDA Approves Sun Pharmaceutical's Generic Drug Application Sun Pharmaceutical Industries Ltd. received FDA approval for its abbreviated new drug application (ANDA076327) on Marc…
# FDA Approves Generic Topiramate from Cipla USA Inc. Cipla USA Inc. received FDA approval for its generic topiramate oral formulation on March 27, 2009, potentially expanding tre…
# FDA Approves Sun Pharmaceutical's Generic Leuprolide Acetate Sun Pharmaceutical Industries, Inc. received FDA approval for its generic leuprolide acetate formulation on March 9,…
Glenmark Pharmaceuticals Inc., USA secured final FDA approval for its generic Lamotrigine oral drug, clearing the path for a cost-effective market entry that is expected to drive c…
# FDA Approves Harrow Eye's TOBRADEX ST for Ophthalmic Inflammation Harrow Eye, LLC has received FDA approval for TOBRADEX ST (tobramycin/dexamethasone), a combination ophthalmic …