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Sivextro Approval History

FDA Approved: Yes (First approved June 20, 2014)
Brand name: Sivextro
Generic name: tedizolid phosphate
Dosage form: Tablets and Injection
Company: Cubist Pharmaceuticals, Inc.
Treatment for: Skin and Structure Infection

Sivextro (tedizolid phosphate) is an oxazolidinone antibiotic drug indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Development History and FDA Approval Process for Sivextro

DateArticle
Jun 20, 2014Approval FDA Approves Sivextro (tedizolid phosphate) to Treat Skin Infections
Jun  6, 2014Cubist Announces Publication of Pivotal Data from Sivextro (tedizolid phosphate) ESTABLISH-2 Trial
Mar 31, 2014FDA Advisory Committee Unanimously Recommends Approval of Sivextro (tedizolid phosphate)
Dec 30, 2013Cubist Announces FDA Acceptance of Tedizolid New Drug Application with Priority Review
Oct 23, 2013Cubist Announces Submission of New Drug Application for Investigational Antibiotic Tedizolid for Treatment of Serious Skin Infections

Further information

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