Drug firm Zydus Cadila on Tuesday said it has received final approval from the US health regulator to market Solifenacin Succinate tablets, used for treatment of overactive bladder. The company has received final approval from the United States Food and Drug Administration (USFDA) to market Solifenacin Succinate tablets, in the strengths of 5 mg and 10 mg, Zydus Cadila, part of the Cadila Healthcare group, said in a regulatory filing.
Solifenacin Succinate is a symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. The company said the newly-approved medication will be manufactured at the group’s formulation manufacturing facility at the special economic zone, Ahmedabad.
The group now has 309 approvals and has so far filed over 390 abbreviated new drug applications since the commencement of the filing process in the financial year 2003-04. Shares of Cadila Healthcare were trading 0.01 percent higher at Rs 422.55 on BSE.