IRVINE, Calif.--(BUSINESS WIRE)-- Allergan, Inc. (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.
ABOUT ALLERGAN, INC.
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: www.allergan.com.
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 www.allergan.com 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.
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