Regulatory briefs: Celgene's pomalidomide; Lundbeck's vortioxetine

21 September 2012

US biotech firm Celgene (Nasdaq: CELG) says that the US Food and Drug Administration’s Oncologic Drugs Advisory Committee will hold a review of the company’s New Drug Application for pomalidomide at its meeting on November 8, 2012.

Celgene is seeking approval to market pomalidomide in combination with dexamethasone as a potential treatment for patients with relapsed and refractory multiple myeloma that has progressed following at least two prior therapies. The agency has set a Prescription Drug User Fee Act (PDUFA) date of February 10, 2013 for completion of the review. Pomalidomide is not approved in the USA for the treatment of multiple myeloma. The drug has been filed with the European Medicines Agency.

Lundbeck updates on novel antidepressant filings

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