PHILADELPHIA, March 20 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced today a voluntary market withdrawal/recall of thirty-nine (39) lots of the ADHD patch DAYTRANA (the lots of DAYTRANA patches affected by this action are listed below). Shire is taking this action because some DAYTRANA patches no longer meet their release liner removal specification, and as a result, patients and caregivers could have difficulties removing the liners.
This action is not due to safety issues. All DAYTRANA patches, including those in the lots listed below, can continue to be used unless the release liner cannot be removed, or the patches are damaged while being opened.
The current supply levels of DAYTRANA should be sufficient to ensure that patients can continue to have their DAYTRANA prescriptions filled at their local pharmacy.
Physicians, patients, and caregivers who have questions about DAYTRANA should call Shire’s DAYTRANA customer service line at 1-800-828-2088, option 1, and pharmacists should call 1-888-202-3822.
Noven Pharmaceuticals, Inc. continues to manufacture and Shire continues to promote DAYTRANA in the United States. DAYTRANA is licensed globally to Shire by Noven. Shire and Noven have notified the United States Food and Drug Administration (FDA) of this voluntary action.
Shire and Noven are committed to continuing ongoing quality assurance monitoring and data analysis of DAYTRANA, and may implement additional voluntary actions. Shire and Noven continue to actively pursue enhancements to DAYTRANA, and are working with the FDA to implement changes intended to enhance the usability of DAYTRANA.
DAYTRANA lots affected by this action are:
2616311*, 2617211*, 2733211* 2570611, 2617011, 2617111, 2656911, 2657211, 2657212, 3014511, 3073511, 2572011, 2732811+, 27328111, 2617811, 2624711, 2625211, 3051911, 31947, 31949, 31951, 33041, 33042, 34172, 2572411, 2572611, 2573211, 2573311, 2573411, 2652411, 2733111, 2737411, 2750111, 3015011, 3015311, 31739, 31920, 31921, 31922, 31923.
*These Lots are subject to a voluntary recall.
+Cartons from Lot 2732811 were re-packaged as Lot 27328111.
SHIRE PLC
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 (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases 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 small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company’s website: www.shire.com.
“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.
