Adapt Pharma Urges FDA Hurdles For Teva Overdose Generic
Law360, New York (November 18, 2016, 7:12 PM EST) -- Adapt Pharma wants the U.S. Food and Drug Administration to require Teva’s generic version of overdose drug Narcan to undergo special scrutiny in order to win approval, according to a newly released citizen petition.
The petition, released Thursday, targets a proposed generic from Teva Pharmaceutical Industries Ltd., which Adapt is already suing for patent infringement, as well as any other generics of Narcan. The brand-name product is a nasal spray that delivers rescue doses of naloxone to patients who overdose on opioids, such as heroin or oxycodone.
It’s common for brand-name drugmakers to file citizen petitions that urge the FDA to...
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