IRVINE, CA, USA I April 16, 2013 I 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.
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.
SOURCE: Allergan
Post Views: 212
IRVINE, CA, USA I April 16, 2013 I 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.
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.
SOURCE: Allergan
Post Views: 212
