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Allergan Receives Complete Response Letter from FDA for Prior Approval Supplement for Restasis

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Additional Relevant Details Allergen announced it has received a Complete Response Letter from the FDA for its Prior Approval Supplement (PAS) for Restasis (Cyclosporine Ophthalmic Emulsion) 0.05%, asking for additional CMC information for the Multi-Dose Preservative-Free (MDPF) bottle.  The bottle is patented with uni-directional valve and air filter technology.  Allergen expects to provide the additional information and submit it to the FDA in a timely manner.
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Occurred on:
Mar 10, 2016
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Related Keywords Restasis, Complete Response Letter, Fda, Chronic Dry Eye Disease, Mdpf Bottle