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Unichem Laboratories gets USFDA nod to market generic capsules

The company has received abbreviated new drug application (ANDA) approval to market its Zonisamide capsules, USP 25 mg, 50 mg and 100 mg from the United States Food and Drug Administration (USFDA), Unichem Laboratories said in a BSE filing.

January 27, 2021 / 04:45 PM IST
 
 
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Drug firm Unichem Laboratories on Wednesday said it has received an approval from the US health regulator to market its generic Zonisamide capsules used for the treatment of partial seizures in adults with epilepsy.

The company has received abbreviated new drug application (ANDA) approval to market its Zonisamide capsules, USP 25 mg, 50 mg and 100 mg from the United States Food and Drug Administration (USFDA), Unichem Laboratories said in a BSE filing.

The product is a generic version of Sunovion Pharmaceuticals Inc's Zonegran capsules in the same strengths, it added.

The capsules will be commercialised from the company's Goa plant, the filing said.

Zonisamide Capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, it added.

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Shares of Unichem Laboratories were trading at Rs 293.35 per scrip on BSE, down 0.19 per cent over previous close.
PTI
first published: Jan 27, 2021 04:45 pm

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