Endo sues FDA over its handling of generic Adrenalin approvals
Endo Pharmaceuticals is suing the FDA over its approval of a generic version of Endo’s Adrenalin injections to treat allergic reactions, requesting an emergency stay on the agency’s decision.
In a 32-page lawsuit filed in the US District Court for the District of Columbia on Monday, Endo argues that the FDA unlawfully approved a generic version of epinephrine, which Endo markets as Adrenalin. Epinephrine is an injection used in the clinical setting to treat anaphylaxis and to increase blood pressure in patients with low blood pressure due to septic shock. The FDA granted final approval for a version of BPI Labs’ epinephrine in February.
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