Strides Pharma Science arm gets US FDA nod for drug to treat overactive bladder
The approved product is a generic version of Vesicare tablets of Astellas Pharma US
Strides Pharma Science said its step-down wholly-owned subsidiary has received approval from the US health regulator for Solifenacin Succinate tablets, used to treat overactive bladder.
The approved product is a generic version of Vesicare tablets of Astellas Pharma US.
Strides Pharma Global, Singapore, has received approval for Solifenacin Succinate tablets, 5 mg and 10 mg, from the United States Food and Drug Administration (US FDA), Strides Pharma Science said in a regulatory filing.
Citing IQVIA data, the company said the US market for Solifenacin Succinate tablets, 5 mg and 10 mg is approximately USD 820 million.
Strides said the product will be manufactured at Alathur facility in Chennai and will be marketed by Strides Pharma in the US market.
The company’s shares were trading 4.61 per cent lower at Rs 313.45 apiece on the BSE.