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Johnson & Johnson, Impax, Isis, Santarus, NuPathe Face Key Dates in January


There are number of FDA drug approvals and reviews scheduled for the first month of 2013.

MINYANVILLE ORIGINAL The new year kicks off with a lot of activity for drug and biotech companies, including some decisions on new drugs that investors will be following closely.

Below are some of the highlights for January catalyst events. Some of the dates are subject to change.

January 7
One of the biggest annual investor events in health care, the JPMorgan Healthcare Conference, runs through January 9 in San Francisco. Drug and biotech companies often make news at the meeting.

January 10
Johnson & Johnson (NYSE:JNJ) faces a panel of expert advisers to the FDA that will review the company's application to sell the drug Invokana for type 2 diabetes. The drug, also known as canagliflozin, was shown in company studies to effectively control blood sugar levels in diabetic patients. Invokana is potentially a big drug for J&J and the company conducted research of more than 10,000 patients to support its bid for US and European market approval.

January 16
Santarus (NASDAQ:SNTS) expects word from the FDA on possible approval of Uceris for the treatment of mild to moderate ulcerative colitis, an inflammatory bowel disease. Santarus, a profitable company, already has four approved drugs, including Glumetza for diabetes. The company's shares are up more than 200% in 2012.

January 17
NuPathe (NASDAQ:PATH) awaits a decision from the FDA on possible market clearance for Zecurity, a patch to treat migraine headaches. Last year, the FDA rejected the product (then called Zelrix), saying it had questions about the product's safety and other issues. (See also: Migraine Patch Maker NuPathe Falls on Rejection.) Shares of NuPathe are up more than 80% in 2012.

January 21
Generic drug maker Impax Laboratories (NASDAQ:IPXL) expects to hear about an approval decision from the FDA on the drug Rytary for Parkinson's disease. Rytary is a lead drug candidate for Impax's branded pharmaceutical division. (See also: Keep an Eye on These Five New Drugs in the First Quarter of 2013.)

January 23
Hyperion Therapeutics (NASDAQ:HPTX) should get word from the FDA on the company's application to sell Ravicti for urea cycle disorder, an inherited disease that prevents a person's body from removing ammonia from blood. Hyperion is a newly public company. The shares are up 6% since they began trading in July.

January 29
Isis Pharmaceuticals (NASDAQ:ISIS) and Sanofi (NYSE:SNY) are expecting a market approval decision from the FDA for the experimental drug Kynamro, a treatment for homozygous familial hypercholesterolemia. In October, a panel of FDA advisers voted 9-6 in favor of approving the drug. Such close votes usually don't bode well for a drug's chances of winning approval. Another company, Aegerion Pharmaceuticals (NASDAQ:AEGR), just won approval for its own drug to treat the condition, a genetic disease that significantly elevates bad cholesterol levels. (See also: Aegerion Pharmaceuticals Wins Approval for Cholesterol Drug.)

January 30
Australian company Pharmaxis (PINK:PXSLY) faces a committee of expert advisers to the FDA as it seeks approval for the inhaled treatment Bronchitol for cystic fibrosis.

Also in January, watch for the sales launch of Amarin's (NASDAQ:AMRN) heart drug Vascepa, which is derived from pure fish oil. The company also is hoping to win additional market exclusivity for the drug, a decision the FDA has delayed over the past several months.

Diet pill maker Arena Pharmaceuticals (NASDAQ:ARNA) awaits word from the Drug Enforcement Administration for scheduling of the drug Belviq. The DEA needs to classify the drug because of risk of abuse.

Some large drug makers, including J&J and Pfizer (NYSE:PFE), will report fourth-quarter and full-year earnings in the second half of the month.

Twitter: @brettchase

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