During the March earnings call, Dr.Reddy’s Lab had said that it plans to launch its female contraceptive product, NuvaRing in the current year. But going by the latest development, there will now be a delay and it is sure to have an impact as this gives the others in the market a window of opportunity.
Dr.Reddy’s said yesterday that it has received a Complete Response Letter from the US FDA for its version of gNuvaRing. The FDA sends this Complete Response Letter when it determines that the drug/product cannot be given an approval in its present form for more than one reason.
Post this development, brokerage houses have now pushed the launch to mid of 2020.
Teva Pharmaceutical Industries Ltd., Mayne Pharma Group Ltd. and Amneal Pharmaceuticals Inc are three other companies which have developed a similar generic product for the American market and they too are awaiting the FDA approval.
Thus as of now, its all up in the air for Dr.Reddy’s and it has now truly become a race – the one who gets the approval first will take it all.
The stock is the top loser on the BSE since opening bell, going down over 8% to Rs.2352. Its 10% LC for today is at Rs.2302.50.