Relpax cleared in USA after four-year review

Pfizer's Relpax (eletriptan hydrobromide) has been approved in the USAfor the treatment of migraine headache after significant delays which saw the New Drug Application languishing at the Food and Drug Administration for four years. The drug is already available in 17 other countries, including Mexico, Italy, France and Japan.

Pfizer first submitted eletriptan for approval in the USA in 1998, but received a knockback from the FDA the following year when the agency asked for more information on drug interactions and potential cardiotoxicity with the product. It had been tipped as a potential $500-million brand, but its commercial potential has been greatly reduced in the face of a raft of competing agents from GlaxoSmithKline, Merck & Co, AstraZeneca and, most recently, UCB/Elan with Frova (frovatriptan; Marketletter June 24, 2002).