ROCKVILLE, Md., June 26, 2012 (CRWENewswire) — Supernus Pharmaceutical drugs, Corporation. (Nasdaq:SUPN), a niche pharmaceutical drugs company, received a tentative approval letter in the Food & Drug Administration (the “Food and drug administration”) for Trokendi XR(TM), a once-daily extended release formulation of topiramate (formerly referred to as SPN-538). The letter states the Food and drug administration completed its overview of the Trokendi XR NDA which no additional clinical tests are needed. Our initial understanding is the fact that final approval is conditioned on solving an advertising and marketing exclusivity problem elevated through the Food and drug administration regarding a particular child population.
“We’re very happy to announce the Food and drug administration granted us tentative approval for Trokendi XR which all the scientific and procedural conditions for approval happen to be met. We will work carefully using the Food and drug administration to help comprehend the outstanding problem and move ahead towards final approval,” stated Jack Khattar, Ceo, Leader and Director of Supernus.
The Organization also found that the Food and drug administration refused the Citizen’s Petition filed this year by Upsher Cruz Labs as it requires its NDA on Trokendi XR.
About Supernus Pharmaceutical drugs, Corporation.
Supernus Pharmaceutical drugs, Corporation. is really a niche pharmaceutical company centered on developing and commercializing items for treating nervous system, or CNS, illnesses. The organization is developing several product candidates in neurology and psychiatry to deal with large market possibilities in epilepsy and Attention deficit hyperactivity disorder including Attention deficit hyperactivity disorder patients with impulsive aggression. These product candidates include Trokendi XR (extended-release topiramate), formerly referred to as SPN-538 and SPN-804 (extended-release-oxcarbazepine) for epilepsy, SPN-810 for impulsive aggression in Attention deficit hyperactivity disorder and SPN-812 for Attention deficit hyperactivity disorder.
Forward Searching Claims
This pr release consists of forward-searching claims regarding the opportunity of Trokendi XR to deal with epilepsy, its final approval, and also the timing of their availability to doctors. Actual results may vary materially from individuals during these forward-searching claims consequently of numerous factors, including, although not restricted to, risks concerning the company’s capability to obtain final approval because of its items, commercialize items effectively, whether doctors will prescribe and patients uses Trokendi XR, once available, and competition looking for Trokendi XR. For any further description of those along with other risks facing the organization, please visit the danger factors referred to within the company’s Registration Statement on Form S-1 which was filed using the U . s . States Investments and Exchange Commission and also the changes thereto, including individuals factors talked about underneath the caption “RisksInch in individuals filings. Forward-searching claims speak only by the date of the pr release, and the organization undertakes no obligation to update or revise these claims, except as might be needed legally.
Jack Khattar, Leader & Boss
Gregory S. Patrick, V . P . and CFO
Supernus Pharmaceutical drugs, Corporation.
Tel: (301) 838-2591
Source: Supernus Pharmaceutical drugs, Corporation.
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