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FDA approves Melinta’s fluoroquinolone antibiotic

June 20, 2017 7:26 PM UTC

FDA approved oral and IV Baxdela delafloxacin from Melinta Therapeutics Inc. (New Haven, Conn.) to treat acute bacterial skin and skin structure infections (ABSSSIs).

Baxdela’s label includes a boxed warning that notes the risks of serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy and CNS effects. Melinta said the broad-spectrum fluoroquinolone antibiotic is active against both Gram-positive and Gram-negative pathogens, including methicillin-resistant Staphylococcus aureus (MRSA)...

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