The USFDA sends the applicant a CRL if the agency determines that it will not approve the application, or ANDA, in its present form for one or more reason
Shares of Dr Reddy's Laboratories fell 1.8 percent intraday on August 16 after the management issued a clarification after receiving a Complete Response Letter (CRL) from the US health regulator over its NuvaRing drug.
The stock had shed 1.8 percent on August 14 on street's expectations of a likely delay in the launch of NuvaRing drug. At 13:06 hours IST, the stock was quoting at Rs 2,479.80, down Rs 31.40, or 1.25 percent, on the BSE.
The management on August 14 said it received a CRL from the US Food and Drug Administration and is preparing its response to it. "Receiving a CRL is ordinary in the course of our business. Hence, we do not have a practice of disclosing any CRL from USFDA on any product," it said.
The USFDA sends the applicant a CRL if the agency determines that it will not approve the application, or ANDA, in its present form for one or more reasons.
NuvaRing is a vaginal ring used to prevent pregnancy.
In related news, global brokerage Citi maintained its sell rating on the stock and slashed its target price to Rs 2,375 from Rs 2,540 per share, citing likely delays in the female contraceptive drug launch after a fresh CRL from the USFDA.The research firm cut its FY20/21/22 EPS estimates by 8/6/1 percent, respectively, assuming the launch of generic NuvaRing in mid-2020. "Nuvaring launch before mid-CY20 is unlikely and a further delay can't be ruled out," it said.Subscribe to Moneycontrol Pro and gain access to curated markets data, trading recommendations, equity analysis, investment ideas, insights from market gurus and much more. Get Moneycontrol PRO for 1 year at price of 3 months at 289. Use code FREEDOM.