FDA approves ABSSSI treatment drug

The U.S. Food and Drug Administration has approved a new drug to treat acute bacterial skin and skin structure infections.

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Orbactiv (oritavancin) is an intravenously administered drug treating ABSSSI infections caused by susceptible bacteria such as Staphylococcus aureus, MRSA, Streptococcus species and Enterococcus faecalis, according to a news release.

This is the third antibacterial drug the FDA has approved this year to treat ABSSSI. Dalvance (dalbavancin) was approved in May and Sivextro (tedizolid) was approved in June, according to the news release.

Orbactiv was designated as a Qualified Infectious Disease Product due to its intention to treat serious or life-threatening infection. Due to its designation, the drug was given priority review, including an expedited review of its application.

More articles on the FDA:

Quicker FDA drug approval leads to increased drug withdrawals
What the latest FDA guidance means for mHealth
FDA proposes exempting certain devices from premarket requirements

 

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