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

Tue Apr 16, 2013 9:00am EDT

* Reuters is not responsible for the content in this press release.

IRVINE, Calif.--(Business Wire)--
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:

        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 12th, 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.
        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 5th.
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 1st, 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) 

Copyright Business Wire 2013

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