3M urges FDA not to approve Ivax generic albuterol MDI before agency responds to citizen's petitions.
3M URGES FDA NOT TO APPROVE IVAX GENERIC ALBUTEROL MDI BEFORE SAFETY ISSUES are resolved and the agency has responded to petitions calling for an advisory committee meeting on the issue. 3M Pharmaceuticals states in a Dec. 7 letter to Center for Drug Evaluation & Research Director Janet Woodcock that it was "surprised to learn from the trade press that [Ivax] will receive an approval prior to year's end of its ANDA for an albuterol metered-dose inhaler product for the treatment of asthma."
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