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# Allergan Complete Response Letter on Restasis Supplement
- URL: https://www.fdaweb.com/allergan-complete-response-letter-on-restasis-supplement/
- Published: 2016-03-10T12:00:00.000Z
- Updated: 2026-09-15T02:42:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135048

> FDA has issued Allergan a complete response letter for its prior approval supplement for Restasis (cyclosporine ophthalmic emulsion) 0.05%, multi-dose preservative-free (MDPF) formulation. In the letter, the agency requested additional CMC information for the MDPF bottle, which the company describes as a “first of its kind container with patented uni-directional valve and air filter technology. Allergan says it is compiling the data requested and will respond in a timely manner. Restasis ws originally approved in 2002 for treating chronic dry eye disease. It works by helping increase the eyes’ natural ability to produce tears.