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Allergan receives FDA response letter for prior approval supplement for Restasis container

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Allergan has received a complete response letter from the FDA for its prior approval supplement for the multi-dose, preservative free bottle for Restasis, according to a company press release.

The FDA requested additional Chemistry, Manufacturing and Controls information for the Restasis (cyclosporine ophthalmic emulsion) 0.05%, multi-dose preservative-free (MDPF) bottle, according to the release.

In the absence of additional requests, “Allergan does not anticipate a significant impact to the previously communicated timelines of the potential approval of the MDPF bottle,” the release said.