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.
FDA gives tentative approval to Perrigo’s generic Epiduo Gel
SILVER SPRING, Md. — The Food and Drug Administration has given its tentative approval for Perrigo’s generic of Epiduo Gel (adapalene and benzoyl peroxide 0.1%/2.5%), the company announced Thursday. The drug is indicated to treat acne vulgaris in patients 12 years of age and older.
Annual sales for the product were $379 million for the 12 months ended July 2016.
“This tentative approval is another example of Perrigo's ongoing commitment to developing high-quality value alternatives in important treatment categories,” Perrigo CEO John Hendrickson said.
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