Sun Pharmaceutical’s arm gets USFDA nod for generic plavix tablets

30 Jul 2011 Evaluate

Sun Pharmaceutical Industries’ subsidiary has been granted a tentative approval from United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for generic version of Plavix, clopidogrel tablets USP.

These generic clopidogrel tablets USP, 75 mg are therapeutic equivalents of Sanofi Aventis’s Plavix tablets. Clopidogrel tablets USP have annual sale of approximately $6 billion in the US.

Clopidogrel tablets USP are indicated for the treatment of acute coronary syndrome, recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease.

Recently, the company’s had announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Uroxatral ER, alfuzosin hydrochloride extended release tablets

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