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Home Industry News Forest Laboratories announces FDA defers final action on milnacipran NDA

Forest Laboratories announces FDA defers final action on milnacipran NDA

21st October 2008

Forest Laboratories and Cypress Bioscience have announced the US Food and Drug Administration (FDA) has advised the companies it was not able to take final action by the planned Prescription Drug User Act action date for their New Drug Application (NDA) for milnacipran.

The scheduled date was October 18th and milnacipran is a selective serotonin and norepinephrine reuptake inhibitor for use in the management of fibromyalgia, the firm states.

It notes the FDA has not requested any further information from either of the firms, but did state that a clinical data question related to the NDA proposal was in need of confirmation.

Forest states both companies continue to prepare for a product launch meeting in the first quarter of next year.

“The FDA indicated that their assessment could be completed in a matter of weeks, but could not confirm specific timing. The FDA could not provide further information as to the reason for the delay,” it concludes.

Earlier this month, Forest and Ironwood Pharmaceuticals announced the presentation of results from a phase IIb study examining the safety and efficacy of linaclotide in a total of 420 patients with irritable bowel syndrome and constipation.

It found a one-daily dose of the therapy significantly reduced abdominal pain.

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