Zydus' Nesher Pharma gets FDA nod market generic ADHD drug

Zydus' Nesher Pharma gets FDA nod to market generic ADHD drug

9:58 AM, 20th July 2019
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NEW DELHI, INDIA: Cadila Healthcare said Zydus' Nesher Pharmaceuticals has received final nod from the US health regulator to market generic version of Adderall XR capsules in the US. Cadila Healthcare is a Zydus group firm.

The final approval from the USFDA is to market Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate extended-release capsules in the strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg, Cadila Healthcare said in a filing to BSE.

The product is a generic version of Adderall XR capsules and will be manufactured at Nesher Pharmaceuticals' manufacturing facility at St Louis in the US, it added.

The drug is indicated for the treatment of attention-deficit hyperactivity disorder (ADHD), it said.

The group now has 269 approvals and has so far filed over 360 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.

Shares of Cadila Healthcare closed at Rs 228.45 per scrip on BSE, down 1.10 per cent from the previous close.




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