Glenmark gets USFDA nod for ADHD drug
New Delhi: Glenmark Pharmaceuticals has received final approval from the US health regulator for generic version of Strattera capsules, used in the treatment of attention-deficit/hyperactivity disorder (ADHD).
“Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration (US FDA) for Atomoxetine capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg, the generic version of Strattera capsules of Eli Lilly and Company,” Glenmark Pharmaceuticals said in a BSE filing.
According to IMS Health sales data for the 12 months to April 2017, Strattera capsules achieved annual sales of approximately $1.1 billion, Glenmark said.
The company’s current portfolio consists of 117 products authorised for distribution in the US marketplace and 67 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.
Glenmark Pharmaceuticals shares were trading up by 1.39 per cent at Rs. 632.95 on the BSE.