Paratek Withdraws European Marketing Authorization Application for Oral and Intravenous NUZYRA in Skin Infections and Pneumonia
Retrieved on:
Thursday, October 17, 2019
Based on the review of the data and the application, the EMA has recommended approval for NUZYRA for the treatment of acute bacterial skin and skin structure infections (ABSSSI) but not for community-acquired bacterial pneumonia (CABP).
Key Points:
- Based on the review of the data and the application, the EMA has recommended approval for NUZYRA for the treatment of acute bacterial skin and skin structure infections (ABSSSI) but not for community-acquired bacterial pneumonia (CABP).
- NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
- Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp.
- PARATEK and the Hexagon Logo are registered trademarks of Paratek Pharmaceuticals, Inc. NUZYRATM and its design logo are trademarks of Paratek Pharmaceuticals, Inc.