The US FDA has granted tentative approval for the Teva Pharmaceutical Industries 's Ivax Abbreviated New Drug Application (ANDA) for Simvastatin tablets USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg.
Upon final approval, the company's Simvastatin tablets will be the AB-rated generic equivalent of Merck's Zocor tablets, a product indicated for the treatment of high cholesterol. Total annual sales of the brand product are approximately $4.6 billion.
As the first company to file an ANDA containing a paragraph IV certification for the 5 mg, 10 mg, 20 mg, and 40 mg strengths, Teva is eligible to receive 180-day Hatch-Waxman statutory exclusivity to market these products.
Further, the FDA filed an appeal to the United States Court of Appeals concerning Teva's 180-day exclusivity. The FDA is challenging a May 1, 2006 decision by the district court, which found unlawful the FDA's October 24, 2005 decision denying the company's citizen's petition on the exclusivity issue. The FDA is seeking expedited review and has proposed a schedule whereby the appeal will be fully briefed over the summer, with arguments to be heard at the court's earliest convenience thereafter. Teva has agreed to an expedited schedule.
Teva expects to receive final approval for the 5 mg, 10 mg, 20 mg, and 40 mg strengths with exclusivity on June 23, 2006, when the product patent expires.