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.
This article is viewable by subscribers only. To view this article, please select an option below.
|