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October 22, 2013

The Food and Drug Administration has approved drugs for depression and smoking cessation made by Jubilant Life Sciences, the company said.

NOIDA, India — The Food and Drug Administration has approved drugs for depression and smoking cessation made by Jubilant Life Sciences, the company said.

Jubilant, based in India, announced the approval of generic bupropion hydrochloride extended-release tablets in the 100-mg, 150-mg and 200-mg strengths, and another bupropion hydrochloride extended-release tablet product in the 150-mg strength.

The first product is a generic version of GlaxoSmithKline's antidepressant Wellbutrin SR, while the second is a version of GSK's anti-smoking drug Zyban.

August 22, 2013

The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

PITTSBURGH — The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

The drug maker announced the approval of its supplemental abbreviated new drug application, or sANDA, for bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL.

August 20, 2013

The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical Cos., the drug maker said Tuesday.

Par announced the approval of bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL and is used to treat major depressive disorder. The company already markets the generic drug in the 150-mg strength.

November 1, 2012

Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

NEW YORK – Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

October 22, 2012

Watson Pharmaceuticals and Actavis will have to divest rights to almost two dozen drugs as a condition for U.S. regulatory approval of their $5.6 billion merger announced earlier this year, according to regulatory documents.

NEW YORK – Watson Pharmaceuticals and Actavis will have to divest rights to almost two dozen drugs as a condition for U.S. regulatory approval of their $5.6 billion merger announced earlier this year, according to regulatory documents.

October 5, 2012

The Food and Drug Administration has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) in the 300-mg strength, manufactured by Impax Labs and Teva Pharmaceuticals USA, is not therapeutically equivalent to Wellbutrin XL in the 300-mg strength.

WASHINGTON — The Food and Drug Administration has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) in the 300-mg strength, manufactured by Impax Labs and Teva Pharmaceuticals USA, is not therapeutically equivalent to Wellbutrin XL in the 300-mg strength.