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Par Pharma gets US FDA approval for bupropion HCL ER tablets

New Jweawy
Wednesday, August 21, 2013, 15:30 Hrs  [IST]

Par Pharmaceutical Companies, Inc., a privately held, US-based specialty pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) for bupropion hydrochloride (HCl) extended-release (ER) tablets USP (XL), 300 mg.  Bupropion HCl ER tablets USP (XL) is the generic version of Wellbutrin XL and is indicated for the treatment of major depressive disorder (MDD).  Par's supply to the market of bupropion HCl ER tablets USP (XL), 150 mg and 300 mg, has been uninterrupted since originally approved in December 2006.

In September 2012, FDA requested all generic drug companies marketing a version of bupropion HCl ER tablets, 300 mg, to conduct a fasting bioequivalence (BE) study comparing their bupropion HCl ER tablets, 300 mg, to GSK's Wellbutrin XL (bupropion hydrochloride extended release) Tablets, 300 mg.  In December 2012, Par submitted a sANDA containing the requested study to FDA, which demonstrated in vivo bioequivalence of Par's bupropion HCl ER tablets USP (XL), 300 mg, to Wellbutrin XL tablets, 300 mg.  In April 2013, Par's sANDA was approved.

Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals.

 

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