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Keeping Track: CDER 2016 Novel Approvals Hold At 22 As US FDA Declines Cempra's Solithera

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The latest drug development news and highlights from our FDA Performance Tracker.

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Second FDA complete response letter for a reformulated Primatene Mist likely pushes back by another 18 months Amphastar's potential relaunch of the OTC product after satisfying the US agency's concerns about consumers correcting using the product without a doctor’s intervention.

Primatene Mist CRL Underscores Challenges For OTC Asthma Treatments

Second FDA complete response letter for a reformulated Primatene Mist likely pushes back by another 18 months Amphastar's potential relaunch of the OTC product after satisfying the US agency's concerns about consumers correcting using the product without a doctor’s intervention.

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Limited population approval pathway in 21st Century Cures law may not help Cempra overcome US agency's request for new 9,000-patient safety study of the macrolide antibiotic.

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