Business Services Industry
NexMed Confirms FDA Acceptance of NDA for Erectle Dysfunction Product
Business Wire, Nov 20, 2007
EAST WINDSOR, N.J. -- NexMed, Inc. (Nasdaq: NEXM), a developer of innovative transdermal products based on its proprietary NexACT[R] drug delivery technology, today announced that the New Drug Application (NDA) filed by the Company for its erectile dysfunction (ED) product, a topically applied alprostadil cream, was accepted for review by the U.S. Food and Drug Administration (FDA).
"We are pleased to announce the FDA's acceptance of our submission for our ED product," stated Vivian Liu, President and Chief Executive Officer of NexMed. "We have already begun working with the agency and with our partner, Warner Chilcott, and look forward to gaining regulatory approval for this important new therapy. I am confident in Warner Chilcott's CEO Roger Boissonneault and his team's ability to establish a major presence in urology. With their proven success in building new markets, Warner Chilcott is a great partner for launching this product, upon its approval."
The acceptance for review is an indication that the FDA has determined that the filing is sufficient to complete a substantive review of the application, which customarily takes a minimum of eight months, should the FDA not require any additional studies or information.
About NexMed
NexMed, Inc. is leveraging its proprietary NexACT[R] drug delivery technology to develop innovative topical pharmaceutical products that address unmet medical needs. NexMed's novel, onychomycosis treatment, licensed to Novartis, is currently in pivotal Phase 3 trials in the U.S. and Europe. NexMed's pipeline also includes a Phase 2 treatment for female sexual arousal disorder and an early stage treatment for psoriasis. For further information about the Company, go to www.nexmed.com.
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to whether and when the FDA will approve the Company's ED Product.
- 5 Rules for Immediate Annuities
- Death in the Family: 12 Things to Do Now
- Dumbest Things You Do With Your Money
- 6 Online Networking Mistakes to Avoid
- 401(k) Mistakes to Avoid
- 5 Economic Scenarios to Keep You Up at Night
- The Real ‘Best Places to Retire’
- Best Credit Cards for You
- 12 Tough Questions to Ask Your Parents
- The Real ‘Best Colleges’
- Home Buyer Tax Credit: How to Cash In
- Why You Shouldn't Bash Cash
- 8 Phony 'Bargains' and Better Alternatives
- Danger: 3 Debit Card Scams to Avoid
- 6 Myths About Gas Mileage
- 29 Fees We Hate Most
- Quick and Easy Ways to Boost Returns
- Best Stocks to Buy Now
- Lower Your Taxes: 10 Moves to Make Now
- New Jobs: 8 Lessons from Real-Life Career Switchers
- The New Job Market: Who Wins and Who Loses?
- Health Care Reform's Public Option: Everything You Need to Know
- Volunteer Work When Unemployed: Should You Work for Free?
- Whose Recovery Is This?
- Long-Term-Care Insurance: 4 Biggest Risks to Avoid
Content provided in partnership with
Most Recent Business Articles
- Multiple criteria evaluation and optimization of transportation systems
- Multi-criteria analysis procedure for sustainable mobility evaluation in urban areas
- A two-leveled multi-objective symbiotic evolutionary algorithm for the hub and spoke location problem
- Multi-criteria analysis for evaluating the impacts of intelligent speed adaptation
- The development of Taiwan arterial traffic-adaptive signal control system and its field test: a Taiwan experience
Most Recent Business Publications
Most Popular Business Articles
- 7 tips for effective listening: productive listening does not occur naturally. It requires hard work and practice - Back To Basics - effective listening is a crucial skill for internal auditors
- FAS 109: a primer for non-accountants - Financial Accounting Standards Board's "Statement 109: Accounting for Income Taxes"
- LIFO vs. FIFO: a return to the basics
- Design a commission plan that drives sales - Sales Commissions
- Using object-oriented analysis and design over traditional structured analysis and design


