Baxdela Approval History

• FDA approved: Yes (First approved June 19th, 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

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

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