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But the agency was just waiting for the right moment. The FDA gave two thumbs-ups yesterday.
The first wasn't so much an approval as an expanded use. Bristol-Myers Squibb's (NYSE: BMY ) Sprycel was already approved for treating chronic myeloid leukemia after patients failed Novartis' Gleevec. Now, the FDA says the drug can be used as a first-line treatment. The expanded approval will increase the potential patient population, but it also has competition on the way. Novartis' Tasigna also beat Gleevec in a recent head-to-head trial, and has been approved as a first-line treatment as well.
The second drug getting an FDA green light was Sunovion Pharmaceuticals' Latuda. Sunovion is owned by Dainippon Sumitomo Pharma, which you can find on the Tokyo Stock Exchange, but I'm not sure Latuda should be the trigger that makes you want to investigate further.
The drug enters the crowded -- dare I say crazy -- schizophrenia market. With AstraZeneca's Seroquel, Pfizer's (NYSE: PFE ) Geodon, and Eli Lilly's (NYSE: LLY ) Zyprexa, not to mention generic versions of Johnson & Johnson's (NYSE: JNJ ) Risperdal, I have a hard time seeing the drug gaining much traction.
Where does the pair of approvals leave Forest Labs (NYSE: FRX ) , Biodel (Nasdaq: BIOD ) , and Avanir Pharmaceuticals (Nasdaq: AVNR ) , which could all hear from the FDA today? In about the same place they were before.
While we can draw some conclusions from the FDA's actions -- the agency seems to be getting more safety-conscious -- drug approvals ultimately boil down to the data on the individual drugs. Forest's ceftaroline looks like a shoo-in, assuming there are no manufacturing issues. Approvals for Biodel's Linjeta and Avanir's AVP-923 look a little iffier, given a weak data package and a history of heart issues, respectively.
A previous version of this article incorrectly stated that Tasigna had not yet been approved as a first-line treatment. The Fool regrets the error.