Ahmedabad, May 02, 2017:Healthcare player Zydus Cadila informed about receiving the final approval from the US drug regulator US Food and Drug Administration (USFDA) to market Olmesartan Medoxomil tablets in the US market.
The approval will allow the company to sell the drug in strengths of 5 mg, 20 mg and 40 mg. This is a day-one approval after the expiry of 181-day exclusivity, Zydus said here.
The drug is an anti-hypertensive and will be produced at the group’s formulations manufacturing facility at the Pharma SEZ in Ahmedabad.
The estimated sales for Olmesartan is $982 million (IMS MAT February 2017), it added.