FDA OKs continued compounding of versions of Makena

SILVER SPRING, Md. — Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.

In February, the FDA approved KV Pharmaceuticals’ Makena (hydroxyprogesterone caproate), an injectable drug widely available in compounding pharmacies. But with Makena costing $1,500 per dose — compared with $10 to $20 for compounded versions of hydroxyprogesterone caproate, also known as 17P — the FDA is permitting compounding pharmacies to continue preparing and dispensing the treatment.

KV had sent letters to pharmacists saying that the FDA no longer would allow them to make compounded versions of 17P, though the FDA said this was not correct.

“We applaud the FDA’s decision,” said George Malmberg, president and CEO of Wedgewood Pharmacy, a compounding pharmacy based in Swedesboro, N.J. “As compounding pharmacy specialists, we have provided physicians and their patients with the compounded version of 17P for many years. Like all concerned, we are committed to making sure that patients at risk have access to this life-saving medication.”

The Society for Maternal-Fetal Medicine praised the FDA’s decision as well. “This action will ensure that this life-saving treatment will continue to be available for all those who need it,” SMFM president George Saade said. “Affordable access to hydroxyprogesterone caproate is critical to ensuring the health and full-term birth of babies in the [United States].”