FDA approves new Dr. Reddy's injectable drug
HYDERABAD, India — The Food and Drug Administration has approved an injected drug for the bone marrow disorder myelodysplastic syndrome made by Dr. Reddy's Labs, the company said Tuesday.
Dr. Reddy's announced the approval of azacitidine injection in the 100-mg-per-vial strength. The drug is a generic version of Celgene's Vidaza, and Dr. Reddy's plans to launch the product in the near future.
Vidaza had sales of about $378.5 million during the 12-month period ended in July, according to IMS Health.