Zydus Cadila receives tentative USFDA nod for overactive bladder drug

Pharmaceutical manufacturer Zydus Cadila said that it has received tentative approval from the US Food and Drug Administration for sales of mirabegron extended-release tablets.

A tentative approval means that the company has to wait for all patent and other protections to expire before starting the sale of the drug.

The tablets, currently sold under the brand name of Myrbetriq, is used to treat overactive bladder. Overactive bladder is a problem with how the bladder stores urine that causes a sudden urge to urinate.

Zydus said its tablets will be sold in doses of 25mg and 50mg and manufactured at the company’s facility in Ahmedabad.

With the latest approval, the company has so far received 259 approvals and filed 350 applications for the sales of its generic drugs.

Headquartered in Ahmedabad, Zydus Cadila has manufacturing sites and research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim and even in the United States and Brazil.