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FDA Asks Lederle to Review Product Line:...

FDA Asks Lederle to Review Product Line: The Food and Drug Administration has asked Lederle Laboratories to review its entire product line after an FDA inspection found that one of its drugs was being made in an unapproved fashion. In an Aug. 24 letter from its New York district office, the FDA said Lederle’s Thiotepa cancer drug was being manufactured in way that had been “significantly changed” from the version approved by the regulatory agency. It also said certain lots of the drug had not been adequately tested to assure that the expiration date on the packaging matched the expected shelf life of the drug.


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