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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 Cubist's Sivextro Tedizolid to treat skin infections
June 21, 2014
 Regulators in the USA have given the green light to Cubist Pharmaceuticals’ antibiotic Sivextro for serious skin infections, including those caused by MRSA.
The US Food and Drug Administration has approved Sivextro (tedizolid) for acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (MRSA) and…
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