Approval for Dr. Reddy's Generic Vidaza - Analyst Blog
Dr. Reddy's Laboratories Ltd. ( RDY ) recently announced the U.S. Food and Drug Administration (FDA) approval of its bioequivalent generic version of Celgene Corporation's ( CELG ) Vidaza. The generic will be launched soon.
Vidaza is approved for the treatment of patients with some of the French-American-British myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocyticleukemia. According to IMS Health, Vidaza generated U.S. revenues of approximately $378.5 million MAT (moving annual total) in the 12 months ending Jul 2013.
Revenues at Dr. Reddy's Global Generics segment were up 15% to $368 million in the first quarter ended Jun 30, 2013. Strong sales in North America and emerging markets led to the growth at the Global Generics division. Generics revenues increased in North America (up 37%), Russia and other CIS (Commonwealth of Independent States) markets (up 8%), and the rest of the world, or RoW (up 12%).
Dr. Reddy's launched 23 new generic products, filed 12 registrations for new products and also filed 5 drug master files (DMFs) globally in the first quarter of 2014.
During the first quarter of fiscal 2014, Dr. Reddy's filed 2 abbreviated new drug applications (ANDAs) with the FDA. As of Jul 30, 2013, Dr. Reddy's had 64 ANDAs pending approval with the FDA, of which 38 are Para IV filings and 8 are first-to-file.
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