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Replidyne receives warning letter for data submitted for NDA

Pharma Compliance Alert, February 27, 2008

A biopharmaceutical company in Louisville, CO., learned the hard way that using another company's clinical trials to file a new drug application (NDA) doesn't always go over well with the FDA.

Replidyne relied on four clinical trials conducted by Bayer to file a NDA for a 300-mg dose of faropenem medoxomil. Instead of approval, the company received a warning letter from the FDA.

The FDA concluded the company "did not adhere to the applicable statutory requirements and regulations governing an applicant's responsibilities concerning submission of data and information to the FDA," according to the warning letter.

The FDA also said Replidyne failed to:

• Make available the underlying raw data from the investigation for the FDA's audit
• Provide adequate descriptions and analyses of any other date or information relevant to the safety and effectiveness of the drug

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