Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for LEVADEX® (dihydroergotamine) New Drug

  Allergan Receives Complete Response Letter from the U.S. Food and Drug
  Administration for LEVADEX® (dihydroergotamine) New Drug Application

Business Wire

IRVINE, Calif. -- April 16, 2013

Allergan, Inc. (NYSE: AGN) today announced that the U.S. Food and Drug
Administration (FDA) has issued a Complete Response Letter (CRL) to its New
Drug Application (NDA) for LEVADEX® (dihydroergotamine) inhalation aerosol for
the acute treatment of migraine in adults.

Allergan is pleased that, in addition to the response, the company has already
received draft labeling from the FDA. Allergan anticipates minimal revisions
to this labeling. The company is committed to bringing LEVADEX® to market as a
potential new acute treatment to address a significant unmet need among the
millions of people living with debilitating migraines.

The main issues cited in the CRL were already identified by the FDA in prior
discussions with Allergan. The company has already taken the following actions
to address these concerns:

1.Per the FDA’s comments in the CRL, during a previous inspection, the
    agency noted concerns with Exemplar Pharma, LLC, the canister filling unit
    manufacturer. In accordance with Allergan’s overall manufacturing strategy
    to secure our supply chain, Allergan completed the acquisition of Exemplar
    on April 12^th, 2013, for less than $20 million. Allergan has appointed
    senior members of Allergan’s Global Technical Operations to oversee the
    facility. Allergan anticipates that the FDA will require a re-inspection
    of the Exemplar facility prior to approval.
2.The FDA also noted concerns regarding the manufacturing process for the
    final filled canisters. Allergan has already responded to this concern. As
    the FDA indicated in the CRL, the Agency has not yet reviewed Allergan’s
    response under the current PDUFA timeline.

Allergan is committed to vigorously address the concerns raised by the FDA in
the CRL. Based on Allergan’s current understanding of the FDA’s CRL, the
company estimates that the next FDA action will occur by the end of Q4 2013.

In addition, based on our assessment of the above, Allergan reiterates
guidance regarding earnings per share (EPS) which was previously issued on
February 5^th. Even with an FDA approval under the original timeline, 2013
sales of LEVADEX® would have been minimal. Today’s FDA response will not
materially impact overall Allergan 2013 sales guidance. In the regular course
of business, Allergan will provide a full update on the company’s Quarterly
Earnings call, which will take place on May 1^st, 2013.


Allergan is a multi-specialty health care company established more than 60
years ago with a commitment to uncover the best of science and develop and
deliver innovative and meaningful treatments to help people reach their life's
potential. Today, we have approximately 10,800 highly dedicated and talented
employees, global marketing and sales capabilities with a presence in more
than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals,
biologics, medical devices and over-the-counter consumer products, and
state-of-the-art resources in R&D, manufacturing and safety surveillance that
help millions of patients see more clearly, move more freely and express
themselves more fully. From our beginnings as an eye care company to our focus
today on several medical specialties, including eye care, neurosciences,
medical aesthetics, medical dermatology, breast aesthetics, obesity
intervention and urologics, Allergan is proud to celebrate more than 60 years
of medical advances and proud to support the patients and physicians who rely
on our products and the employees and communities in which we live and work.
For more information regarding Allergan, go to:


This press release contains "forward-looking statements," including statements
regarding the FDA Complete Response Letter and Allergan’s ability to address
FDA’s concerns within the estimated time period, anticipated revisions to
LEVADEX® labeling, the acquisition of Exemplar, safety, effectiveness,
approval and market potential of LEVADEX®, and guidance regarding 2013 sales
and earnings per share (EPS). 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 and medical device
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. Allergan expressly disclaims any intent or obligation to
update these forward-looking statements except as required by law. Additional
information concerning these and other risks can be found in press releases
issued by Allergan, as well as Allergan's public filings with the U.S.
Securities and Exchange Commission, including the discussion under the heading
"Risk Factors" in Allergan's most recent Annual Report on Form 10-K and any
subsequent Quarterly Reports on Form 10-Q. Copies of Allergan's press releases
and additional information about Allergan are available on the World Wide Web
at or you can contact the Allergan Investor Relations
Department by calling 1-714-246-4636.

© 2013 Allergan, Inc. Irvine, CA 92612.

LEVADEX is a registered trademark of Map Pharmaceuticals, Inc., a wholly-owned
subsidiary of Allergan, Inc.


Bonnie Jacobs, 856-912-9965; 714-246-5134; (media)
Cathy Taylor, 949-293-4453; 714-246-5551; (media)
Jim Hindman, 714-246-4636 (investors)
Joann Bradley, 714-246-4766 (investors)
David Nakasone, 714-246-6376 (investors)
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