Lupin gets tentative approval on Avelox generic
SILVER SPRING, Md. — The Food and Drug Administration has given Lupin’s U.S. arm, Gavia Pharmaceuticals, a tentative approval for its generic of Avelox (moxifloxacin HCl) tablets, the company announced Tuesday.
The drug will be available from Lupin in 400-mg dosage strength, and the product had U.S. sales of $30.1 million for the 12 months ended June 2016, according to IMS Health data.
FDA approves expanded indication for Amgen’s Blincyto
SILVER SPRING, Md. — The Food and Drug Administration has approved Amgen’s supplemental Biologics License Application for an expanded indication for its Blincyto, the company said Thursday.
The drug is now approved for treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The indication was granted under accelerated approval.
Dr. Reddy’s launches generic Wellbutrin SR
HYDERABAD, India and PRINCETON, N.J. — Dr. Reddy’s Laboratories announced Friday the U.S. launch of its generic of Wellbutrin SR (bupropion HCl) extended-release tablets.
Brand and generic sales of the drug were $109.6 million for the 12 months ended July 2016, according to IMS Health. The Dr. Reddy’s generic will be available in 60-, 100- and 500-count bottles in 100-, 150- and 200-mg dosage strengths.
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