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FDA Approves Expanded Indication for Qudexy XR (Topiramate) for Pediatric Patients

Maple Grove, MN – June 1, 2015 – Upsher-Smith Laboratories, Inc. (Upsher-Smith) announced that it has received U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) for Qudexy XR (topiramate) extended-release capsules for use as initial monotherapy in patients two years of age and older who are experiencing partial-onset seizures (POS) or primary generalized tonic-clonic seizures.

Qudexy XR capsules are the only once-daily extended-release topiramate product to have received this expanded indication and to be approved for administration by sprinkling their contents onto soft food, making them a useful option for young children who may have difficulty swallowing whole capsules or tablets.

Qudexy XR is a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

“The expanded indication gives physicians the option to prescribe Qudexy XR as initial monotherapy in patients as young as two years old,” said William Pullman, MB BS, BMedSc, PhD, FRACP, Chief Scientific Officer, Upsher-Smith. “This, combined with its ability to be sprinkled on soft food for ease of administration, makes it a viable treatment option for the pediatric patient population.”

Qudexy XR was previously approved for use as initial monotherapy in patients 10 years of age and older with POS or primary generalized tonic-clonic seizures. Qudexy XR is also approved as an adjunctive therapy in patients two years of age or older with POS, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Qudexy XR has been available in the United States since June 2014.

About Upsher-Smith

Upsher-Smith Laboratories, Inc., founded in 1919, is a growing, fully integrated pharmaceutical company dedicated to its mission of delivering high-value, high-quality therapies and solutions which measurably improve individuals’ lives. As a family-owned pharmaceutical company, we are able to adapt and thrive in a dynamic healthcare environment. Our world is constantly evolving, and we are continually adapting to the ever-changing needs of patients, physicians, pharmacists, and healthcare organizations. Where there is a need, we will work to deliver solutions that simplify access to treatment, deliver better health outcomes, and enhance life. Upsher-Smith has a particular focus on developing therapies for people living with central nervous system (CNS) conditions, such as seizure disorders. For more information, visit www.upsher-smith.com.

Reference

1. Epilepsy.com. Available at: http://www.epilepsy.com/learn/epilepsy-statistics. Accessed May 8, 2015.

Source: Upsher-Smith Laboratories, Inc.

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