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Keeping Track: US FDA Refuses To File Acorda, SteadyMed NDAs

 
• By Sue Sutter

Issues involving inspectional readiness and the drug master production record cited in agency's refusal to review Acorda's Inbrija in Parkinson's disease; SteadyMed faces request for additional design verification and validation testing for drug/device combo Trevyent in pulmonary arterial hypertension.

The US FDA turned away two new drug applications (NDAs) submitted under 505(b)(2) in the last week of August – actions that, once again, highlight the fallacy of viewing this regulatory pathway as an easier route to approval relative to a regular 505(b)(1) NDA.

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