Par Pharmaceutical Receives Approval of sANDA for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg
WOODCLIFF LAKE, N.J., Aug. 20, 2013 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it has received approval from the U.S. 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.
Important Information About Bupropion HCl ER Tablets (XL)
Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a seizure disorder, in patients treated with ZYBAN® (bupropion hydrochloride extended-release tablets (XL)); WELLBUTRIN® (bupropion hydrochloride tablets), the immediate-release formulation; WELLBUTRIN SR® (bupropion hydrochloride extended-release tablets (SR)), the sustained-release formulation; or any other medications that contain bupropion because the incidence of seizure is dose dependent, in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in patients treated for bulimia with the immediate-release formulation of bupropion, and in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).
The concurrent administration of bupropion hydrochloride extended-release tablets (XL) and a monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion hydrochloride extended-release tablets (XL).
Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up bupropion hydrochloride extended-release tablets (XL).
A black box warning is associated with this product regarding Suicidality and Antidepressant Drugs. Refer to full prescribing information for complete boxed warning.
About Par Pharmaceutical Companies, Inc.
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. For press release and other company information, visit www.parpharm.com.
SOURCE Par Pharmaceutical Companies, Inc.