U.S. Senator Bernie Sanders this week urged regulators to allow pharmacies and manufacturers to resume distributing unbranded, lower-cost versions ...
REUTERS: U.S. Senator Bernie Sanders this week urged regulators to allow pharmacies and manufacturers to resume distributing unbranded, lower-cost versions of a drug used to treat a rare neuromuscular disorder, according to a letter provided by his office to Reuters.
The program allows patients with rare diseases and conditions access to experimental drugs outside of a clinical trial when there is no viable alternative. FDA approval of Makena came years after pharmacies had already been compounding such a drug at far lower prices than Makena, using an active ingredient, hydroxyprogesterone, available without formal FDA approval.
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