SpaceX Pushes for Early Stock Index Inclusion Ahead of Potential Record-Breaking IPO 
Nvidia, ByteDance, and the U.S.-China AI Chip Standoff Over H200 Exports 
Global PC Makers Eye Chinese Memory Chip Suppliers Amid Ongoing Supply Crunch 
Baidu Approves $5 Billion Share Buyback and Plans First-Ever Dividend in 2026 
Missouri Judge Dismisses Lawsuit Challenging Starbucks’ Diversity and Inclusion Policies 
SoftBank Shares Slide After Arm Earnings Miss Fuels Tech Stock Sell-Off 
SpaceX Prioritizes Moon Mission Before Mars as Starship Development Accelerates 
Trump Backs Nexstar–Tegna Merger Amid Shifting U.S. Media Landscape 
Hims & Hers Halts Compounded Semaglutide Pill After FDA Warning 
Washington Post Publisher Will Lewis Steps Down After Layoffs 
Alphabet’s Massive AI Spending Surge Signals Confidence in Google’s Growth Engine 
Prudential Financial Reports Higher Q4 Profit on Strong Underwriting and Investment Gains 
CK Hutchison Launches Arbitration After Panama Court Revokes Canal Port Licences 
American Airlines CEO to Meet Pilots Union Amid Storm Response and Financial Concerns 
OpenAI Expands Enterprise AI Strategy With Major Hiring Push Ahead of New Business Offering 
Weight-Loss Drug Ads Take Over the Super Bowl as Pharma Embraces Direct-to-Consumer Marketing 
WARREN, N.J., Feb. 07, 2017 -- MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for Tadalafil Oral Soluble Film (Tadalafil OSF) for the treatment of erectile dysfunction. The Tadalafil OSF NDA has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2017.
“The acceptance of the NDA and assignment of a PDUFA target action date is an important milestone that puts Tadalafil OSF one step closer to potential approval,” said Dan Barber, Vice President of MonoSol Rx. “Based on the success of our pivotal pharmacokinetic study in 2016 and our status as the first film alternative to tadalafil tablets to file for FDA approval, we believe that our product has significant potential and is well-positioned to compete in the multi-billion dollar erectile dysfunction market. Through our engagement with ESC Advisors, we are continuing to explore partnership opportunities for Tadalafil OSF and look forward to advancing this process as we move closer to our PDUFA date.”
Tadalafil is a PDE5 inhibitor currently marketed in tablet form for the treatment of erectile dysfunction and benign prostatic hyperplasia (BPH) under the brand name Cialis®, and for treatment of pulmonary arterial hypertension under the brand name Adcirca®. Tadalafil OSF will be offered in single pack doses and is expected to have several Orange Book listed patents upon approval.
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm drug delivery technology to develop products that improve patient outcomes and address unmet needs. PharmFilm can benefit patients by improving the efficacy, safety, convenience, and compliance of pharmaceutical products. MonoSol Rx's leadership in film drug technology is supported by strong IP protection, a robust pipeline of prescription drug formulations, and two FDA-approved products — Suboxone® (buprenorphine and naloxone) sublingual film and Zuplenz® (ondansetron) oral soluble film. For press releases and other company information, visit www.monosolrx.com.
Contact MonoSol Rx Jessica Patel [email protected] The Ruth Group Lee Roth [email protected] (646) 536-7012
