Nov. 8 (Bloomberg) -- KV Pharmaceutical Co. gained the most in nine months after U.S. regulators said they are investigating pharmacies that make low-cost versions of the company’s drug to prevent premature births.
KV rose 61 percent to $1.44 at 3:23 p.m. New York time after gaining as much as 83 percent, the biggest intraday rise since Feb. 4 when the drug, marketed as Makena, was approved.
Pharmacies make, or compound, their own versions of Bridgeton, Missouri-based KV’s drug. The Food and Drug Administration tends to allow compounding pharmacists to operate outside the normal rules at its discretion, the agency said in a March 30 statement on Makena.
After the drug was approved, the agency decided to allow compounding pharmacies to continue providing the medicine, also known as 17-P.
“FDA has begun its own sampling and analysis of compounded hydroxprogesterone caproate products” and the active ingredients “used to make them,” the FDA said today in a statement.
The investigation is based on information from KV regarding the potency and purity of samples of the bulk active ingredient and compounded finished product, the FDA said.
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