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Drug Industry Daily
June 19, 2012 | Vol. 11 No. 120
FDA Finds No Major Safety Issues With Compounded Makena But Emphasizes Approved Drugs’ Superiority
The FDA is encouraging use of approved versions of KV Pharmaceutical’s pre-term birth drug Makena and bulk active pharmaceutical ingredients (APIs), rather than compounded versions, even after an agency analysis of a limited sample did not find any major safety concerns with the compounded drug.
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