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Bayer ciprofloxacin DPI gets orphan drug status from the FDA

The FDA has granted orphan drug designation to a ciprofloxacin DPI being developed by Bayer HealthCare for the treatment of non-cystic fibrosis bronchiectasis, the company has announced. The dry powder formulation, based on Novartis’s PulmoSphere platform, is delivered using the T-326 (Podhaler) DPI. The product is currently in Phase 3 trials.

Bayer is also developing an amikacin DPI in partnership with Nektar. That product is also in Phase 3 development.

Read the Bayer Healthcare press release.

published on

April 22, 2014

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