Zydus Cadila said it received the final approval to sell urine leakage drug Oxybutynin Chloride in the US market.
The annual US sales of the drug is about $150.9 million, it said.
The US FDA approved dosages of 5 mg, 10 mg, and 15mg. The drug is largely available in generic format.
The medicine is used to treat symptoms of overactive bladder and urinary incontinence (urine leakage).
Urine leakage is the accidental release of urine when the person coughs, laughs, sneezes, or jogs. It can also happen on the way to the bathroom.
It will be produced at the group’s formulation manufacturing facility at Moraiya in Ahmedabad.
With this, Zydus Cadilla group has more than 120 approvals, it said. The company has filed over 300 abbreviated new drug applications — for generics — since 2003.
Zydus Cadila employs over 20000 people worldwide.