Dr Reddy’s NDA approved for migraine drug by FDA

The company’s NDA (new drug application) Elyxyb (celecoxib oral solution 25 mg/mL) has been approved by the US Food and Drug Administration (FDA), according to Dr Reddy’s Laboratories.

The latest product emerging from Dr Reddy’s portfolio of successful acute migraine treatments is Elyxyb (previously known as DFN-15), which is indicated for the acute treatment of migraine with or without aura in adults. The company is also working to commercialise this product through its partners, according to a press release from the city-based drug maker.

Erez Israeli, CEO, Dr Reddy’s Laboratories, said, “We are excited about the approval of Elyxyb. It reaffirms our commitment to innovation and to develop meaningfully differentiated products that address significant unmet needs of patients and physicians, leading to better health outcomes,”

A demonstration has also been laid down by Anil Namboodiripad, Sr Vice President of Proprietary Products Group, Dr Reddy’s, in pivotal studies, Elyxyb -a rapid onset of action which is critically important to patients suffering from acute migraine attacks.

Namboodiripad further added that, “The results from the studies established the efficacy of celecoxib in the treatment of migraine with very few adverse events.”


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