Posted by Michael Wonder on 28 Nov 2017
FDA issues guidance that could make it easier for EpiPen rivals to come to market
28 November 2017 - FDA issued guidance that says generic copies with some design differences may be approved as substitutable products.
When the controversy over the price of the EpiPen exploded late last summer, many consumers asked why there was no substitutable generic version available.
The answer was complex: while the key ingredient in the anaphylaxis treatment, epinephrine, has been available for decades and is no longer covered by a patent, the delivery device proved hard for generic competitors to copy to a degree that would satisfy regulators.
Tuesday, the FDA announced guidance seeking to change that, potentially streamlining a path to market for generic copies of complex medicines like the EpiPen and others.
