Life Sciences

Two pharma companies barred from manufacturing unapproved drugs

Pharma Compliance Alert, April 15, 2009

The FDA barred Neilgen Pharmaceuticals and its parent company, Advent Pharmaceuticals from manufacturing or distributing unapproved drugs, according to an agency release.

Neilgen and Advent manufacture and distribute more than 25 different unapproved drug products each. Most are prescription cough and cold products. Because these products have not gone through FDA testing, their safety and effectiveness is unknown. In addition, the FDA has not reviewed the adequacy and accuracy of the directions for use and warnings on the labeling.

Read more about the FDA's action against Advent and Neilgen

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