Allergan gets Complete Response Letter from FDA for Restasis bottle

15 March 2016

Allergan (NYSE: AGN) has received a Complete Response Letter from the US Food and Drug Administration for its Prior Approval Supplement for its Restasis (cyclosporine ophthalmic emulsion) container.

The FDA has requested additional chemistry, manufacturing, and control (CMC) information for the Multi-Dose Preservative-Free (MDPF) bottle, a first of its kind container with patented uni-directional valve and air filter technology.

Allergan is compiling the data requested and will respond to the FDA in a “timely manner”.

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