Cyberattacks against accounting software firm Wolters Kluwer and the City of Baltimore in May showed how the newest wave of malicious hacking can have significant, often...Technologyread more
The European parliamentary election is the second largest democratic exercise in the world.Europe Newsread more
Buybacks have gotten a bad rap from both Republicans and Democrats. But stocks would be trading at a massive discount without them.Marketsread more
Biden had criticized Kim Jong Un as a "dictator" and a "tyrant" at a recent rally in Philadelphia. North Korean state media responded by calling Biden a "fool of low IQ" among...Politicsread more
Fiat Chrysler and France's Renault could soon partner up to take on the sweeping changes to the global auto industry, according to a report in the Financial Times. The...Autosread more
Microsoft shares have gained 133% since November 2015, outperforming a tech "basket of unicorns" over that stretch.Technologyread more
The president's state visit comes amid tensions with carmaker Toyota over potential auto tariffs. Trump has repeatedly threatened Japanese and European carmakers with tariffs.Traderead more
The IRS is about to release a new draft of Form W-4, which will more closely reflect the changes stemming from the Tax Cuts and Jobs Act. For workers, that means they'll need...Personal Financeread more
The Mega Millions jackpot has spilled over $400 million. It would be the ninth largest winning since the game began in 2002.Personal Financeread more
Trump was speaking at a meeting of Japanese business leaders in Tokyo during his state visit to Japan on Saturday.Marketsread more
The biggest U.S. gasoline price surge in years is running out of steam just in time for the start of the summer driving season.Energyread more
ROCKVILLE, Md., Oct. 22, 2015 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) announced today that the United States Food and Drug Administration (FDA) has accepted for review the company's supplemental new drug application (sNDA) for Trokendi XR®. The application requests FDA approval to expand the indication for Trokendi XR beyond the current indication for the treatment of epilepsy to include treatment for adults for prophylaxis of migraine headache. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has set a target date in the second quarter of 2016 to complete its review.
"Now that our application is under review, we look forward to working with the FDA to ensure a timely approval of the new indication," said Jack Khattar, president and chief executive officer of Supernus Pharmaceuticals. "If approved for use in migraine, Trokendi XR would represent an important new treatment option for adult patients suffering from this condition."
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system, or CNS, diseases. The Company markets two products for epilepsy, Oxtellar XR® (extended-release oxcarbazepine) and Trokendi XR® (extended-release topiramate). The Company is also developing several product candidates in psychiatry to address large market opportunities in ADHD, including ADHD patients with impulsive aggression. These product candidates include SPN-810 for impulsive aggression in ADHD and SPN-812 for ADHD.
Forward Looking Statements
This press release contains forward-looking statements regarding the timing of the Company's ability to market Trokendi XR® for migraine. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, the Company's ability to obtain final regulatory approval for the migraine indication, commercialize its products successfully, whether physicians will prescribe and patients will use its products, once available, and competition in their respective markets. For a further description of these and other risks facing the Company, please see the risk factors described in the Company's Annual Report Form 10-K that was filed with the United States Securities and Exchange Commission on March 12, 2015 under the caption "Risk Factors". Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as may be required by law.
CONTACT: Contact: Jack A. Khattar, President and CEO Gregory S. Patrick, Vice President and CFO Supernus Pharmaceuticals, Inc. 301-838-2591 Or Investor Contact: Peter Vozzo Westwicke Partners Office: (443) 213-0505 Mobile: (443) 377-4767 Email: firstname.lastname@example.org
Source:Supernus Pharmaceuticals, Inc.