Allergan Receives Action Letter for Oral Tazarotene
IRVINE, Calif., Sep 27, 2004 (BUSINESS WIRE) -- Allergan, Inc. (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a non-approvable letter for tazarotene capsules (oral tazarotene) for the treatment of psoriasis.
In addition to other questions posed, the FDA's letter listed three non-approvability issues for oral tazarotene for the treatment of psoriasis:
-- 1. The development of an acceptable risk management program.
Allergan is in the process of developing an appropriate risk
management plan.
-- 2. Completion of a non-inferiority study in severe psoriasis.
Allergan will work with the FDA to clarify this request.
-- 3. Satisfaction of an FDA deficiency letter regarding the
manufacture of the oral tazarotene capsules. Allergan believes
this issue is either resolved or will be resolved shortly to
the FDA's satisfaction.
"The FDA has invited Allergan to request a meeting to work through the open issues regarding oral tazarotene, which we will do," said Dr. Scott Whitcup, Allergan's Executive Vice President, Research and Development. "Allergan will continue to work with the FDA toward our goal of bringing oral tazarotene to patients suffering from psoriasis."
About Allergan, Inc.
Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator, skin care and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.
Forward-Looking Statements
This press release contains "forward-looking statements," including the statements by Dr. Whitcup, statements regarding research and development outcomes, efficacy, and market and product potential. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include general industry and pharmaceutical market conditions; general domestic and international economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product marketing such as the unpredictability of market acceptance for new pharmaceutical and biologic products and/or acceptance of new indications for such products; potential difficulties in manufacturing a new product formulation; domestic and foreign health care reforms; the timing and uncertainty of the research and development and regulatory processes; trends toward managed care and health care cost containment; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Certain Factors and Trends Affecting Allergan and its Businesses" in Allergan's 2003 Form 10-K and Form 10-Q for the quarter ended June 25, 2004. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
SOURCE: Allergan, Inc.
Allergan, Inc., Irvine Jim Hindman, 714-246-4636 (Investors) Joann Bradley, 714-246-4766 (Investors) Ashwin Agarwal, 714-246-4582 (Investors) Stephanie Fagan, 714-246-5232 (Media) Caroline Van Hove, 714-246-5134 (Media)
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