A generic version of the antidepressant Wellbutrin SR, is being shipped by Mylan Inc. after the Food and Drug Administration gave its nod.
Mylan revealed that FDA declared Mylan's version of the drug in 100 milligram, 150 milligram and 200 milligram doses. GlaxoSmithKline made the brand name version of Wellbutrin SR.
Mylan Pharmaceuticals Inc. received approval for two abbreviated new drug applications, i. e., the high blood pressure tablet and its antidepressant drug. FDA also approved of Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/12.5 mg blood pressure drug, which is a generic version of antihypertensive drug Hyzaar.
Bupropion Hydrochloride Extended-Release Tablets in strengths of 100 mg, 150 mg and 200 mg have also been approved by FDA.
A tentative approval for 50 mg/12.5 mg and 100 mg/25 mg strengths of its antihypertensive drug, Losartan Potassium and Hydrochlorothiazide Tablets has also been received by Mylan. It will be finally approved on or around October 4, 2010.
The approval of about 141 abbreviated new drug applications by FDA is pending, which represent about $96.2 billion in annual brand sales. 38 out of these pending files are potential first-to-file opportunities.












