Allergan Receives Complete Response Letter from FDA for Prior Approval Supplement for RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05% Multi-Dose Preservative-Free Bottle

Mar 10, 2016, 08:00 ET from Allergan plc

DUBLIN, March 10, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its Prior Approval Supplement (PAS) for RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%, Multi-Dose Preservative-Free (MDPF) presentation.

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The FDA requested additional 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. In the absence of additional data requests from the FDA, Allergan does not anticipate a significant impact to previously communicated timelines of the potential approval of the MDPF bottle.

RESTASIS®, approved by the U.S. Food and Drug Administration in 2002, is the only eye drop that helps increase the eyes' natural ability to produce tears, which may be reduced by inflammation due to Chronic Dry Eye disease. RESTASIS® did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.

About Chronic Dry Eye
Chronic Dry Eye is caused by reduced tear production due to inflammation.  Dry eye is often a chronic disease that can be caused by advanced age, contact lens wear, certain medications, eye diseases, other medical conditions, or environmental factors. Without enough tears, the film protecting the eye can break down, creating dry spots on the cornea.

About RESTASIS®
RESTASIS® helps increase the eyes' natural ability to produce tears, which may be reduced by inflammation due to Chronic Dry Eye disease. RESTASIS® did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.

Important Safety Information
Do not use RESTASIS® if you are allergic to any of the ingredients. To help avoid eye injury and contamination, do not touch the vial tip to your eye or other surfaces. RESTASIS® should not be used while wearing contact lenses. If contact lenses are worn, they should be removed prior to use of RESTASIS® and may be reinserted after 15 minutes. The most common side effect is a temporary burning sensation. Other side effects include eye redness, discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision.

Please click here for full Prescribing Information. 

About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world. 

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan's website at www.allergan.com.

Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

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SOURCE Allergan plc



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