This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

2013 FDA Drug Approval Decision Calendar

Stocks in this article: PATH ISIS RPTP CELG IMGN DEPO BIIB MAPP NAVB DCTH AVEO HPTX

BOSTON ( TheStreet) -- Here's an updated list of biotech and pharmaceutical companies with FDA drug approval decisions expected in 2013.

Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst -- FDA drug approval decisions and advisory panels.

Johnson & Johnson (JNJ)
Drug/indication: Canagliflozin for diabetes.
FDA advisory panel: Jan. 10
Approval decision date: March 29

Theravance (THRX)
Drug/indication: Vibativ for hospital acquired pneumonia
Approval decision date: Jan. 11

Santarus (SNTS)
Drug/indication: Uceris for ulcerative colitis
Approval decision date: Jan. 16

NuPathe (PATH)
Drug/indication: Zelrix for migraine
Approval decision date: Jan. 17, 2013

Impax Labs (IPXL)
Drug/indication: IPX066 for Parkinson's disease
Approval decision date: Jan. 21

Hyperion Therapeutics (HPTX)
Drug/indication: Ravicti for urea cycle disorder
Approval decision date: Jan. 23

Sanofi (SNY) and Isis Pharmaceuticals (ISIS)
Drug/indication: Kynamro for dyslipidemia/hypercholesterolemia
Approval decision date: Jan. 29, 2013

Raptor Pharmaceutical (RPTP)
Drug/indication: RP103 for cystinosis
Approval decision date: Jan. 30, 2013

Hemispherx Biopharma (HEB)
Drug/indication: Ampligen for chronic fatigue syndrome
Approval decision date: Feb. 1, 2013

Celgene (CELG)
Drug/indication: Pomalidomide for multiple myeloma
Approval decision date: Feb. 8, 2013

Dynavax (DVAX)
Drug/indication: Heplisav for hepatitis B prevention
Approval decision date: Feb. 22, 2013

Roche (RHHBY) and Immunogen (IMGN)
Drug/indication: T-DM1 for breast cancer
Approval decision date Feb. 26

Zogenix (ZGNX)
Drug/indication: Zohydro for chronic pain
Approval decision date: March 1, 2013

Depomed (DEPO)
Drug/indication: Serada for menopause
FDA advisory panel: March 4
Approval decision date: May 31

Bristol-Myers Squibb (BMY)
Drug/indication: Eliquis for blood clot prevention
Approval decision date: March 15

A.P. Pharma (APPA)
Drug/indication: APF530 for chemotherapy induced nausea
Approval decision date: March 27

Biogen Idec (BIIB)
Drug/indication: BG-12 for multiple sclerosis
Approval decision date: March 28

MAP Pharma (MAPP)
Drug/indication: Levadex for migraine
Approval decision date: April 15

Sucampo Pharmaceuticals (SCMP)
Drug/indication: Amitzia for opioid-induced constipation
Approval decision date: April 26

Navidea Biopharmaceuticals (NAVB)
Drug/indication: Lymphoseek, a radioactive tracing agent for lymph node mapping
Approval decision date: April 30

GlaxoSmithKline (GSK)
Drug/indication: Dabrefenib for melanoma
FDA advisory panel: June 3

Delcath Systems (DCTH)
Drug/indication: ChemoSat for liver metastases due to ocular melanoma
Approval decision date: June 14

AVEO Pharmaceuticals (AVEO)
Drug/indication: Tivozanib for kidney cancer
Approval decision date: July 28

Companies with drugs filed to FDA but no assigned approval decision dates:

Auxillium Pharmaceuticals (AUXL): Xiaflex for Peyronie's disease
Bayer and Algeta: Alpharadin for prostate cancer
Antares Pharma (ATRS): Otrexup for rheumatoid arthritis
GlaxoSmithKline: Dolutegravir for HIV

Sources: Company reports, TheStreet research, BioMedTracker

--Written by Adam Feuerstein in Boston.



>To contact the writer of this article, click here: Adam Feuerstein.

>To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein.

>To submit a news tip, send an email to: tips@thestreet.com.

Follow TheStreet on Twitter and become a fan on Facebook.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,907.78 +102.98 0.58%
S&P 500 2,073.15 +2.50 0.12%
NASDAQ 4,777.3040 +11.9240 0.25%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs