Teva Wins Tentative Approval of Generic Lipitor
The FDA has granted tentative approval for the Company's Abbreviated New Drug Application for Atorvastatin Calcium Tablets.
Teva Pharmaceutical Industries Ltd. announced Thursday that the U.S. FDA has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium Tablets.
This product is the generic version of Pfizer's Lipitor?. Annual sales of Lipitor? were approximately $7.8 billion in the United States as of September 2011, based on IMS sales data.
Teva anticipates launching this product at the end of Ranbaxy's 180-day exclusivity period in May 2012.
A portion of the profits from Ranbaxy's sales of Atorvastatin Calcium Tablets during Ranbaxy's 180-day first-to-file exclusivity period will be paid to Teva. Ranbaxy has la
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