Dr. Reddy’s Laboratories stock fell 8% intraday on Wednesday on the back of an update from the company about the US Food and Drug Administration (USFDA) communication that is likely to have a bearing on the early launch of two generic products.
“Received Complete Response Letter (CRL) from USFDA; Preparing for response,” is what the company had said in an investor update for August 2019 on the launch of the generic versions of Copaxone and NuvaRing.
According to USFDA, a CRL is issued to an applicant “if the agency determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons...” Copaxone (glatiramer acetate injection) is indicated for relapsing forms of multiple sclerosis, NuvaRing is used to prevent pregnancy.
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Meanwhile, the stock recovered some lost ground and closed at ₹2,511.20, 1.83% lower from the previous close. In response to a clarification sought by the exchange, Dr. Reddy’s mentioned the update provided the previous day to investors as well as referred to the earnings call on July 29 when it had pointed to possible queries from USFDA on NuvaRing.