FDA defers approval of Dr Reddys generic Copaxone, NuvaRing

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Published: August 14, 2019 3:01 PM

Copaxone (glatiramer acetate injection) is a multi-billion dollar drug and a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis.

NuvaRing is a small, flexible vaginal ring used to prevent pregnancy. Dr Reddys shares fell by 1.5 per cent to 2,519.55 per share over previous close on BSE at 14.20 hrs on Wednesday.

Dr Reddys Laboratories Limited has said it received a complete response letter from the US Food and Drug Administration (USFDA)for its versions of NuvaRing, a birth control device, and Copaxone (glatiramer acetate injection) for treatment of sclerosis. The FDA would send the applicant the letter if the agency determines that it would not approve the application or abbreviated application in its present form for one or more of the reasons. gCopaxone and gNuvaring received the complete response letter from USFDA, preparing for response, ” Dr Reddys said in its latest investor presentation.

Copaxone (glatiramer acetate injection) is a multi-billion dollar drug and a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis.

Natco Pharmas marketing partner Mylan had already launched the generic version of the same drug in USA market in October 2017. NuvaRing is a small, flexible vaginal ring used to prevent pregnancy. Dr Reddys shares fell by 1.5 per cent to 2,519.55 per share over previous close on BSE at 14.20 hrs on Wednesday.

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