March 31, 2011
Company news: K-V Pharmaceutical and Ther-Rx
In a blow to K-V Pharmaceutical, the FDA said it will not take action against pharmacies that make hydroxyprogesterone caproate, the active ingredient in K-V's recently approved pre-term labor prevention drug Makena. K-V had sent a letter to pharmacists indicating that the agency will no longer allow them to make or compound the injectable drug. “This is not correct,” said FDA in a statement, adding it would not pursue enforcement unless the compounded products are unsafe, of substandard quality or are not compounded according to standards. K-V's branded drug subsidiary Ther-Rx started promoting Makena in March.