FDA
announced on August 16, 2018 that it has given approval to Teva
Pharmaceuticals’ generic version of EpiPen and EpiPen Jr. (epinephrine)
auto-injector in 0.3 mg and 0.15 mg strengths for the emergency treatment of
allergic reactions, including anaphylaxis. While the agency has approved other
epinephrine auto-injectors before, this is the first authorized direct competitor
to Mylan’s EpiPen.
The
epinephrine auto injector is a combination product, consisting of a drug and a
device, that automatically injects a dose of epinephrine into a person’s thigh
to stop an allergic reaction. The development of generic versions of
combination products, such as EpiPen, has been challenging, according to FDA,
because of their complex nature.
“Today’s
approval of the first generic version of the most-widely prescribed epinephrine
auto-injector in the US is part of our longstanding commitment to advance
access to lower cost, safe, and effective generic alternatives once patents and
other exclusivities no longer prevent approval,” said FDA Commissioner Scott
Gottlieb, M.D. “This approval means patients living with severe allergies who
require constant access to life-saving epinephrine should have a lower-cost
option, as well as another approved product to help protect against potential
drug shortages. The path to developing generic drug-device combination products
like this one is challenging.”
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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Pharmaceutical Microbiology