FDA gives tentative approval to Intelliject device

Food and Drug Administration tentatively approves e-cue for allergic reactions; legal issues remain

RICHMOND, Va. — The Food and Drug Administration has given tentative approval to an emergency treatment for severe allergic reactions made by Intelliject, the drug maker said.

The FDA granted the tentative approval to e-cue, an epinephrine auto-injector for allergic reactions, including anaphylaxis. Tentative approval means that a product meets the agency's conditions for final approval but outside issues prevent it from hitting the market. In this case, King Pharmaceuticals and Meridian Medical Technologies have filed a patent infringement suit against Intelliject, alleging that it infringes on its patent for the EpiPen, also an auto-injector used for allergic reactions.

The company said it was confident the dispute with King and Meridian would be "favorably resolved."

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