New Delhi: Zydus Group firm Cadila Healthcare said Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA, has received final approval from the US health regulator to market Dextroamphetamine Sulfate and Amphetamine Sulfate tablets.
Nesher has received final approval from the United States Food and Drug Administration (USFDA) to market the tablets in the strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg, Cadila Healthcare said in a filing to BSE.
The drug will be produced at Nesher’s manufacturing facility at St Louis, MO, USA, it added.
The tablets are used for treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy, Cadila said.
The group now has over 165 approvals and so far filed more than 300 abbreviated new drug applications (ANDAs) since the commencement of the filing process, it added.
Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 507.70 per scrip on BSE, up 2.01 percent from its previous close.