Pharma Company Sues FDA

The maker of a pregnancy medication takes action against the federal agency for not stopping pharmacies from making and selling cheaper versions of the drug.

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St. Louis-based K-V Pharmaceuticals, which makes a hormone injection for reducing the risk of pre-term births, is suing the US Food and Drug Administration (FDA) for not stopping pharmacies from offering a cheaper, self-made preparation of the medicine. The FDA-approved Makena hit the market early last year, originally retailing at $1,500 per injection. However, for years, pharmacies had been making compounded versions of the product using the drug’s active ingredient, hydroxyprogesterone, and selling them for $10 to $20 a pop, Reuters reported.

K-V Pharmaceuticals has been trying to deter pharmacies from doing this by sending warning letters and threatening with lawsuits, prompting accusations of price-gouging by insurance companies, lawmakers, and the public. In light of the company’s plummeting share prices and the looming threat of ...

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