Shire Announces that the US Food and Drug Administration has Responded to its Citizen Petition for Adderall XR and has Approved One Abbreviated New Drug Application for Generi...
PHILADELPHIA, June 23, 2012 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that on June 22, 2012, the US Food and Drug Administration (FDA) responded to Shire's Adderall XR citizen petition. The FDA's response requires that all abbreviated new drug applications (ANDAs) have to establish bioequivalence using partial area under the curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine. The FDA response is consistent with its recent decisions on other long acting ADHD products.
The FDA also informed Shire on June 22, 2012 that it has approved the ANDA for generic Adderall XR filed by Actavis. The FDA has not approved any other Adderall XR ANDAs.
Shire believes that it will remain competitive in the Adderall XR marketplace through the distribution of branded Adderall XR and through its two authorized generic partners, Teva and Impax. While recognizing that there will be multiple dynamics affecting the overall market following the approval of the Actavis generic, Shire continues to believe that it will deliver good, full year 2012 earnings growth.
Notes to editors
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively s