Aurobindo Pharma Ltd (APL) has obtained tentative approval from the US Food and Drug Administration (USFDA) for the company's Simvastatin tablets 5 mg, 10 mg, 20 mg, 40 mg and 80 mg. Zocor, Merck's brand name for Simvastatin, is the second largest brand in the US with over $5-billion annual sales and is one of the fast growing brands. In a press release here on Monday, the company said Simvastatin tablets are going off patent on June 23. The drug is indicated for the treatment of high cholesterol. Aurobindo manufactures both active pharmaceutical ingredient and finished formulations for Simvastatin tablets USP 5 mg, 10 mg, 20 mg, 40 mg and 80 mg. The company said approval of Simvastatin, known to be a difficult product requiring intense R&D capabilities, once again demonstrates its R&D skills.
