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Baxdela Approval History

FDA Approved: Yes (First approved June 19, 2017)
Brand name: Baxdela
Generic name: delafloxacin
Dosage form: Tablets and Injection
Company: Melinta Therapeutics
Treatment for: Skin and Structure Infection

Baxdela (delafloxacin) is a fluoroquinolone antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.

Development History and FDA Approval Process for Baxdela

Jun 19, 2017Approval Melinta Therapeutics Announces FDA Approval of Baxdela (delafloxacin) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Oct 24, 2016Melinta Therapeutics Submits Baxdela New Drug Application for Hospital-Treated Skin Infections
Feb 11, 2014Melinta Therapeutics Raises $70 Million to Support Delafloxacin NDA and Selection of Multi-Drug Resistant Gram-Negative Candidates from RX-04 Platform
May 14, 2013Rib-X Pharmaceuticals Initiates Delafloxacin Global Phase 3 Clinical Trial in Patients with Acute Bacterial Skin and Skin Structure Infections
Dec 15, 2011Rib-X Reports Positive Top-Line Data from Phase 2b Study of Delafloxacin in Patients with Acute Bacterial Skin and Skin Structure Infections
Jan  6, 2011Rib-X Announces Publication Demonstrating Superior Infection Site Potency for Delafloxacin against Gram-positive Pathogens

Further information

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