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CHMP Recommends Approval of Two Antibiotics, Including One Generic

March 9, 2020

The EMA’s Committee for Medicinal Products for Human Use (CHMP) gave its blessing for European Commission approval of two drugs at its February meeting, including a generic version of Pfizer’s skin infection medication Tygacil (tigecycline).

The committee issued a positive opinion for Accord Healthcare’s generic tigecycline for treating complicated skin and soft tissue infections and complicated intra-abdominal infections.

It also recommended approval of Shionogi’s novel antibiotic Fetcroja (cefiderocol) for treating infections caused by aerobic Gram-negative bacteria in adults with limited treatment options.

The committee shot down an extended indication for Eli Lilly’s Emgality (galcanezuma) for prevention of attacks in adults with episodic cluster headaches.

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