The US Food and Drug Administration (FDA) has approved Strides Pharma Science Ltd’s triamcinolone acetonide ointment, which is used to treat various skin infections, the company said in a release on Friday.
While there only a few companies had applied for the generic of the product, another company beat Strides Pharma for the approval, due to which the Indian firm will be able to launch the product only by 30 May, as per the release.
First movers for a generic product in the US usually get a six-month exclusivity period to market the product.
As per market research firm IQVIA, the US market for the product is approximately $20 million.
The ointment will be manufactured at the company’s flagship plant at Bengaluru, and will be marketed by the company’s subsidiary Strides Pharma Inc in the US.
The company has 102 cumulative generic drug filings with US FDA, of which 33 are pending approval
News Source:- Livemint