Zydus Cadila arm gets USFDA nod for generic version of Adderall XR capsules in US

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.

New Delhi: Cadila Healthcare Friday said Zydus' Nesher Pharmaceuticals has received a 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.

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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.

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