K-V sues FDA over Makena in fight for survival
WASHINGTON (Reuters) – 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. . . .
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