This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Intellipharmaceutics Files ANDA With FDA For 30 Mg Focalin XR(R)

TORONTO, Dec. 7, 2010 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), today announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for approval to market a generic of the 30 mg strength of Focalin XR® (dexmethylphenidate hydrochloride). The application for the 30 mg strength is filed as an amendment to the ANDA that Intellipharmaceutics had previously filed for the 5, 10, 15 and 20 mg strengths of the drug.

"The filing of the 30 mg Focalin XR®ANDA is the fourth ANDA we have filed with the FDA in the last 12 months," commented Dr. Isa Odidi, CEO of Intellipharmaceutics. "This filing demonstrates our ability to quickly and efficiently develop controlled release products in-house for filing with the FDA."

In November 2009, the FDA approved the higher 30 mg dose of Focalin XR® extended-release capsules for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The new strength provides physicians with an additional treatment option that offers statistically significant improvement in ADHD symptoms for up to 12 hours compared with the placebo. According to IMS Health, Focalin XR® had U.S. sales of about US$355 million in 2009; the Company projects sales growth for 2010 to approximately US$420 million.

Intellipharmaceutics' application for approval of generic versions of Focalin XR® remains subject to FDA approval. No assurance can be given as to whether or when the FDA will approve the Company's generic versions of Focalin XR®.

About Intellipharmaceutics

Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel or generic controlled release and targeted release oral solid dosage drugs. The Company's patented Hypermatrixâ„¢ technology is a multidimensional controlled-release drug delivery platform that the Company believes can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology, Intellipharmaceutics has a pipeline of products in various stages of approval and development in therapeutic areas that include neurology, cardiovascular, GIT, pain and infection.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

DOW 18,232.02 -53.72 -0.29%
S&P 500 2,126.06 -4.76 -0.22%
NASDAQ 5,089.3620 -1.4320 -0.03%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs