Glenmark Pharma, USA has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Hydrocortisone Valerate Ointment USP, a generic version of Westcort1Ointment of Sun Pharma.
Glenmark has been granted a competitive generic therapy (CGT) designation for Hydrocortisone Valerate Ointment USP. With this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercialization.
This is Glenmark’s first granted CGT product approved by the FDA.
Glenmark’s current portfolio consists of 145 products authorized for distribution in the U.S. marketplace and 55 ANDA’s pending approval with the U.S. FDA.
The stock price has reacted positively to this news, with the price surging 4.5% to Rs.698, which is too not far fetched from its 52-week high of Rs.711.