Content about bupropion hydrochloride

November 27, 2012

Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

SILVER SPRING, Md. — Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

October 22, 2012

Watson, Actavis divest more drugs as condition for FTC merger approval

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

FDA issues new guidelines for budeprion XL in the 300-mg strength

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.

September 4, 2012

FDA approves Wockhardt antidepressant

The Food and Drug Administration has approved a generic antidepressant made by Wockhardt, the Indian drug maker said Tuesday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic antidepressant made by Wockhardt, the Indian drug maker said Tuesday.

Wockhardt announced the FDA approval of its bupropion hydrochloride extended-release tablets in the 100 mg, 150 mg and 200 mg strengths.

The drug is a generic version of GlaxoSmithKline's Wellbutrin SR, various versions of which have a market of about $268 million, according to IMS Health.

September 22, 2011

Orexigen, FDA work out plan for path to approval of obesity drug

Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

SAN DIEGO — Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

February 1, 2011

FDA declines to approve Contrave

The Food and Drug Administration has turned down an application for an anti-obesity drug.

SAN DIEGO — The Food and Drug Administration has turned down an application for an anti-obesity drug.

Orexigen Therapeutics and Takeda Pharmaceutical said Tuesday that the FDA had issued a complete response letter for their application for Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets.

September 30, 2010

Mylan's generic Wellbutrin XL enters market

Mylan has launched a generic version of a common antidepressant, the company said Friday....

PITTSBURGH Mylan has launched a generic version of a common antidepressant, the company said Friday.

Mylan announced the launch of bupropion hydrochloride extended-release tablets in the 150-mg and 300-mg strengths, a once-daily treatment for depression.

The drug is a generic version of GlaxoSmithKline’s Wellbutrin XL. Various versions of the drug had sales of around $752 million during the 12-month period ended in June, according to IMS Health.

July 20, 2010

Caraco launches generic Wellbutrin SR

Generic drug maker Caraco Pharmaceutical Labs has launched a generic antidepressant, Caraco said Wednesday....

DETROIT Generic drug maker Caraco Pharmaceutical Labs has launched a generic antidepressant, Caraco said Wednesday.

The drug maker announced the launch of bupropion hydrochloride extended-release tablets in the 150 mg and 200 mg strengths.

The drug is a generic version of GlaxoSmithKline’s Wellbutrin SR. Various versions of the drug have annual sales of $300 million, according to Caraco.