Unichem gets USFDA nod for Solifenacin Succinate tablets to treat overactive bladder

Solifenacin Succinate Tablet is a generic version of Vesicare Tablets of Astellas Pharma US, Unichem said.

New Delhi: Drug firm Unichem Laboratories has received approval from the US health regulator for Solifenacin Succinate Tablets.

The company has received ANDA approval from US FDA for Solifenacin Succinate Tablets, in the strength 5 mg and 1 0 mg, Unichem said in a filing.

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The approved product is a generic version of Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc.

Solifenacin Succinate Tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Unichem said that the product will be commercialized from Unichem's Goa plant.

Founded in 1944 by Padmabhushan Amrut V Mody, Unichem Labs is currently active in Finished Formulations, APIs, Contract Manufacturing, Custom Synthesis etc. Their RnD Site at Goa has expertise in product development, process chemistry and developing complex APIs for the global market.

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