Benzinga

España
Italia
대한민국
日本
Français
Benzinga Edge
Benzinga Research
Benzinga Pro

  • Get Benzinga Pro
  • Data & APIs
  • Events
  • Premarket
  • Advertise
Contribute
España
Italia
대한민국
日本
Français

Benzinga

  • Premium Services
  • Financial News
    Latest
    Earnings
    Guidance
    Dividends
    M&A
    Buybacks
    Interviews
    Management
    Offerings
    IPOs
    Insider Trades
    Biotech/FDA
    Politics
    Healthcare
    Small-Cap
  • Markets
    Pre-Market
    After Hours
    Movers
    ETFs
    Options
    Cryptocurrency
    Commodities
    Bonds
    Futures
    Mining
    Real Estate
    Volatility
  • Ratings
    Analyst Color
    Downgrades
    Upgrades
    Initiations
    Price Target
  • Investing Ideas
    Trade Ideas
    Long Ideas
    Short Ideas
    Technicals
    Analyst Ratings
    Analyst Color
    Latest Rumors
    Whisper Index
    Stock of the Day
    Best Stocks & ETFs
    Best Penny Stocks
    Best S&P 500 ETFs
    Best Swing Trade Stocks
    Best Blue Chip Stocks
    Best High-Volume Penny Stocks
    Best Small Cap ETFs
    Best Stocks to Day Trade
    Best REITs
  • Money
    Investing
    Cryptocurrency
    Mortgage
    Insurance
    Yield
    Personal Finance
    Forex
    Startup Investing
    Real Estate Investing
    Prop Trading
    Credit Cards
    Stock Brokers
Research
My Stocks
Tools
Free Benzinga Pro Trial
Calendars
Analyst Ratings Calendar
Conference Call Calendar
Dividend Calendar
Earnings Calendar
Economic Calendar
FDA Calendar
Guidance Calendar
IPO Calendar
M&A Calendar
Unusual Options Activity Calendar
SPAC Calendar
Stock Split Calendar
Trade Ideas
Stock Reports
Insider Trades
Trade Idea Feed
Analyst Ratings
Unusual Options Activity
Heatmaps
Free Newsletter
Government Trades
Perfect Stock Portfolio
Easy Income Portfolio
Short Interest
Most Shorted
Largest Increase
Largest Decrease
Calculators
Margin Calculator
Forex Profit Calculator
100x Options Profit Calculator
Screeners
Stock Screener
Top Momentum Stocks
Top Quality Stocks
Top Value Stocks
Top Growth Stocks
Compare Best Stocks
Best Momentum Stocks
Best Quality Stocks
Best Value Stocks
Best Growth Stocks
Connect With Us
facebookinstagramlinkedintwitteryoutubeblueskymastodon
About Benzinga
  • About Us
  • Careers
  • Advertise
  • Contact Us
Market Resources
  • Advanced Stock Screener Tools
  • Options Trading Chain Analysis
  • Comprehensive Earnings Calendar
  • Dividend Investor Calendar and Alerts
  • Economic Calendar and Market Events
  • IPO Calendar and New Listings
  • Market Outlook and Analysis
  • Wall Street Analyst Ratings and Targets
Trading Tools & Education
  • Benzinga Pro Trading Platform
  • Options Trading Strategies and News
  • Stock Market Trading Ideas and Analysis
  • Technical Analysis Charts and Indicators
  • Fundamental Analysis and Valuation
  • Day Trading Guides and Strategies
  • Live Investor Events
  • Pre-market Stock Analysis and News
  • Cryptocurrency Market Analysis and News
Ring the Bell

A newsletter built for market enthusiasts by market enthusiasts. Top stories, top movers, and trade ideas delivered to your inbox every weekday before and after the market closes.

  • Terms & Conditions
  • Do Not Sell My Personal Data/Privacy Policy
  • Disclaimer
  • Service Status
  • Sitemap
© 2026 Benzinga | All Rights Reserved
December 14, 2018 4:02 PM 2 min read

Supernus Announces FDA Approval of sNDA to Expand Oxtellar XR® Label to Include Monotherapy

by Globe Newswire
Follow
SUPN Logo
SUPNSupernus Pharmaceuticals Inc
$55.21-%
Overview

ROCKVILLE, Md., Dec. 14, 2018 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASADQ: SUPN) announced today that the United States Food and Drug Administration (FDA) has approved the Company's supplemental new drug application (sNDA) for Oxtellar XR®. The application requested FDA approval to expand the indication for Oxtellar XR® beyond the current indication of adjunctive therapy in the treatment of partial-onset seizures in adults and in children 6 to 17 years of age.

"We are pleased with the timely approval of the expanded indication for Oxtellar XR. We look forward to launching Oxtellar XR in the first quarter 2019 as a new monotherapy treatment option for partial-onset seizures. We believe that expanding the indication to include monotherapy represents an additional growth opportunity for Oxtellar XR," said Jack Khattar, president and chief executive officer of Supernus Pharmaceuticals.

About Oxtellar XR®

Oxtellar XR is the first approved novel, oral once-daily extended release formulation of oxcarbazepine for the treatment of partial-onset seizures in patients 6 years of age and older. The product is available in 150mg, 300mg, and 600mg extended-release tablets.

For full prescribing and safety information https://oxtellarxr.com/assets/OxtellarXRPrescribingInformation.pdf

About Supernus Pharmaceuticals, Inc.

Forward Looking Statements

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: [email protected]

Market News and Data brought to you by Benzinga APIs

© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

To add Benzinga News as your preferred source on Google, click here.


Posted In:
Press Releases

Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company currently markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, and Oxtellar XR® (extended-release oxcarbazepine) for the treatment of partial seizures. The Company is also developing several product candidates to address large opportunities in the CNS market, including SPN-810 for the treatment of Impulsive Aggression in ADHD patients, SPN-812 for the treatment of ADHD, and SPN-604 for the treatment of bipolar disorder.

This press release contains forward-looking statements regarding the timing of the Company's ability to market Oxtellar XR® for monotherapy treatment in epilepsy. 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 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 set forth from time to time in the Company's SEC filings made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. 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.

SUPN Logo
SUPNSupernus Pharmaceuticals Inc
$55.21-%
Overview
Comments
Loading...