Allergan Comments on Today’s Follow up by the U.S. Food and Drug Administration (FDA) to Its Early Communication, Concluding the Agency’s Safety Review of Botulinum Toxins

Allergan, Inc. (NYSE: AGN) today provided a further clarification on the U.S. Food and Drug Administration’s (FDA) conclusion to its "Early Communication” regarding a safety review of botulinum toxins in the United States.

On February 8, 2008, the FDA announced in an "Early Communication” that it was reviewing certain serious adverse events following the use of botulinum toxins. At the time, the FDA hosted a public teleconference, explaining that the review involved only a "relative handful of serious adverse events” and that the primary focus of the adverse events and the FDA’s review of them related to the therapeutic use of BOTOX^® to treat juvenile cerebral palsy and other large muscle, lower limb spasticities, particularly at higher doses in neurologically compromised patients.

Both before and after the Early Communication on February 8, 2008, Allergan provided adverse event reporting information and analyses from its safety database to the FDA. Yesterday and today, the FDA took three actions:

In its update to the early communication and press conference, the FDA explained the results of its analysis and its conclusion that there have been infrequent reports of serious adverse events associated with potential spread of product from the site of injection and that the risk is greatest in children treated for juvenile cerebral palsy but also in adults treated for spasticity or cervical dystonia who have underlying conditions that would predispose them to these symptoms. The proposed boxed warning provides similar context. Dr. Ellis Unger, M.D., Deputy Director (Acting) of the FDA’s Office of Drug Evaluation, answered questions and clarified the following in the press conference:

Finally, to provide additional context, it is important to understand that while bulk botulinum toxin is a potent biological agent, BOTOX^® is not bulk botulinum toxin. Instead, it is a finished medical product and a vial of BOTOX^® contains an extraordinarily minute amount (only four billionths of a gram) of botulinum toxin. BOTOX^® does not contain clostridium botulinum spores and does not cause botulism at labeled doses.

Allergan will work with the FDA to appropriately update the label for BOTOX^® and BOTOX^® Cosmetic in light of the FDA’s conclusions. In the interim, caution should be exercised if treating neurologically vulnerable patients with high doses of BOTOX^®. Allergan would also like to emphasize the following precautions:

• No other botulinum toxin is interchangeable with BOTOX^® or BOTOX^® Cosmetic and caution should be exercised when substituting another botulinum toxin for BOTOX^® or BOTOX^® Cosmetic.
• Patients should seek immediate medical attention if they develop the following symptoms: unexpected loss of strength or muscle weakness, hoarseness or trouble talking (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.

Important BOTOX^® and BOTOX^® Cosmetic (Botulinum Toxin Type A) Information

BOTOX^® is indicated for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.

BOTOX^® is also indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.

The efficacy of BOTOX^® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane’s syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX^® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.

And BOTOX^® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

BOTOX^® Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18-65.

Important BOTOX^® and BOTOX^® Cosmetic (Botulinum Toxin Type A) Safety Information

BOTOX^® and BOTOX^® Cosmetic treatment should not be injected in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation.

Serious heart problems and serious allergic reactions have been reported rarely. If you think you’re having an allergic reaction or other unusual symptoms, such as difficulty swallowing, speaking or breathing, call your doctor immediately. Individuals with peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should only receive BOTOX^® or BOTOX^® Cosmetic with caution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic side effects with BOTOX^® or BOTOX^® Cosmetic. For full prescribing information, please visit www.botox.com and www.botoxcosmetic.com.

BOTOX^® for Blepharospasm in Patients = 12 Years of Age: Reduced blinking from BOTOX^® injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal perforation. The most frequently reported treatment-related adverse reactions in these patients are ptosis (20.8%), superficial punctate keratitis (6.3%) and eye dryness (6.3%).

BOTOX^® for Strabismus in Patients = 12 Years of Age: Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, double vision or past pointing. The most commonly reported adverse effects are ptosis (16%) and vertical deviation (17%).

BOTOX^® for Cervical Dystonia in Adults: There have been rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube. The most frequently reported adverse reactions in patients with cervical dystonia are dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).

BOTOX^® for Severe Primary Axillary Hyperhidrosis Inadequately Managed with Topical Agents: The most frequently reported adverse events (3 - 10%) are injection site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.

BOTOX^® Cosmetic for Temporary Improvement in the Appearance of Moderate to Severe Frown Lines Between the Brows in Adults 18-65: The most common side effects following injection include temporary eyelid droop and nausea. Localized pain, infection, inflammation, tenderness, swelling, redness and/or bleeding/bruising may be associated with the injection.

Forward-Looking Statements

This press release contains "forward-looking statements,” including statements regarding the safety, effectiveness and adverse events associated with BOTOX^®. 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, among other things, general industry, biologic and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; inconsistency of treatment results among patients; potential difficulties in manufacturing; 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 "Risk Factors" in Allergan's 2008 Form 10-K. 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.

About Allergan, Inc.

Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential – to see more clearly, move more freely, express themselves more fully. The Company employs approximately 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.