FDA Approves FINASTERIDE — Accord Healthcare, Inc.
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…
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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…
Amneal Pharmaceuticals has received FDA approval for the generic tramadol hydrochloride oral formulation, tapping into a high-demand asset used for managing moderate to moderately …
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…
CVS Pharmacy announced the approval of ANDA090685 for PURELAX (polyethylene glycol 3350) on October 6, 2009, marking a significant move that intensified competition in the over-the…
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…
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…
Teva Pharmaceutical announced Friday that it received FDA approval for its Abbreviated New Drug Application, referred to as M-10099, aimed at boosting the adrenocorticotropic hormo…
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…