FDA approves Dr Reddy’s NDA for migraine drug

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FDA approves Dr Reddy’s NDA for migraine drug

Dr Reddy’s Laboratories Ltd said the companys NDA (new drug application) Elyxyb ((celecoxib oral solution 25 mg/mL) has been approved by the US Food and Drug Administration.

Elyxyb (previously known as DFN-15), which is indicated for the acute treatment of migraine with or without aura in adults, is the latest product emerging from Dr Reddy’s portfolio of successful acute migraine treatments.

The company is working to commercialize this product through partners,a press release from the city-based drug maker said on Wednesday.

“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,” Erez Israeli, CEO of Dr Reddy’s Laboratories said.

According to Anil Namboodiripad, Sr. Vice President of the Proprietary Products Group, Dr Reddy’s, in pivotal studies, Elyxyb demonstrated a rapid onset of action which is critically important to patients suffering from acute migraine attacks.

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

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