(ADPnews) - Aug 31, 2010 - Swedish pharma company Meda AB (STO:MEDA A) said today the US Food and Drug Administration (FDA) has postponed the date for a potential marketing approval for its anti-epileptic drug candidate ezogabine to November 30.
The original prescription drug user fee act (PDUFA) goal date had been August 30.
The new drug application (NDA) for ezogabine (known as retigabine outside the USA) was filed on October 30, 2009.
However, the FDA has not yet completed the review of the application as a formal risk evaluation and mitigation strategy (REMS), aimed at ensuring that the benefits of the drug outweigh its risks, was submitted …
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