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Home Industry News Covidien announces new FDA action review date for Exalgo

Covidien announces new FDA action review date for Exalgo

1st December 2009

Covidien has revealed that the Food and Drug Administration (FDA) has submitted a new date for the review of its new drug application (NDA) for Exalgo.

Along with its partner Neuromed Pharmaceuticals, Covidien recently provided the FDA with extra information, which was considered to be a major amendment to the NDA.

Exalgo, a once-daily treatment, has been suggested by the firms as a therapy for moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period.

Timothy Wright, president of pharmaceuticals at Covidien, commented: “We are committed to providing patients with advanced pain medications and are optimistic that Exalgo will be approved. We will continue working with Neuromed and the agency on securing approval for Exalgo.”

Last month, Covidien posted its financial results for the fourth fiscal quarter of 2009, revealing that its net savings amounted to $2.7 billion (1.6 billion pounds) during the timeframe.

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