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KV Rises After FDA Opens Probe of Drug-Compounding Pharmacies

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.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.

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