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Baxdela FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

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, Pneumonia

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

Development timeline for Baxdela

Oct 24, 2019Approval FDA Approves Baxdela (delafloxacin) for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)
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

Further information

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