K-V Pharmaceutical Co is suing the U.S. Food and Drug Administration for not cracking down on compounded versions of its premature birth drug Makena, in a last-ditch fight for the company’s survival. Makena is an injectable hormonal medicine that reduces the risk of pre-term birth in women who have already delivered early in the past. K-V got approval to sell Makena last year, giving it a new lease on life after it was barred from making and marketing its own drugs due to repeated manufacturing problems. But pharmacies had already been compounding a similar, and far cheaper, drug for years for people who had a prescription from a doctor. They use the active ingredient hydroxyprogesterone that has been available on the market without formal FDA clearance.
