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Drugs for Rare and Infectious Diseases
FDA Drug Approvals for Rare Diseases and Infectious Diseases Generating Antibiotics Incentives Now Act GAIN Act (S.1734)
The GAIN Act provides incentives to help bring new antibiotics and other antimicrobials to market.
A drug with particular promise can be designated as a Qualified Infectious Disease Product (QIDP) by authority of the GAIN Act.
In 2014, FDA/CDER approved four new antibiotics…
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FDA approves Orbactiv to treat skin infections ....Third new antibacterial drug approved for this use this year
FDA approves Orbactiv to treat skin infections ….Third new antibacterial drug approved for this use this year
ORITAVANCIN
August 6, 2014
Releasehttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm408475.htm
The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible…
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