Another month is here -- this Fool's favorite one -- and we've got plenty of drugs due for decisions by the Food and Drug Administration. Before we begin with the individual drugs, a couple of brief reminders about decision dates:
- The Prescription Drug User Fee Act (PDUFA) sets a goal for the FDA to review drug marketing applications within 10 months for standard reviews and six months for priority reviews.
- The PDUFA dates come from those goals, but they can -- and most recently will -- be missed.
- Don't try and jump in and out around the PDUFA date. Find a drug owned by a drugmaker you like and buy when the price is right and hold until the FDA makes a decision -- whenever that may be.
Double dose of diabetes drugs
A pair of diabetes drugs that had FDA advisory panel meetings last week could hear about their approvals this month, but investors shouldn't hold their breath -- Eli Lilly
AstraZeneca and Bristol-Myers Squibb
While the regulatory risk for Onglyza is minimal -- I think it's likely that the FDA will give the drug an OK eventually -- it's not clear that the drug will be a big seller. Onglyza is in the same class as Merck's
The PDUFA date for Novo Nordisk's
Me, too!
Johnson & Johnson's
Golimumab's future in Europe is less certain -- not in terms of whether it'll get approved, but who will market it. Schering-Plough
Worth a closer look
Here's a few more drugmakers that could hear about their drugs this month:
Company |
Drug |
Comments |
---|---|---|
Discovery Labs |
Surfaxin |
After three approvable letters, will the drug to treat respiratory death syndrome finally get past the agency? |
Medicis |
Reloxin |
Even if it gets past the FDA, launching a competitor to Allergan's Botox might be tough. |
Savient Pharmaceuticals |
Puricase |
The drugmaker got a priority review because of the lack of treatments for gout, but that doesn't guarantee success. |
Binary events are what make investing in drug companies so lucrative, and risky. Just make sure you do plenty of homework and keep the small ones like Discovery Labs and Savient at a fraction of your portfolio.