Unfortunately for Eli Lilly and Co. (NYSE: LLY), the FDA has rejected its application to sell a once-a-month injectable version of its schizophrenia drug Zyprexa.
 
The pharmaceutical company announced that the FDA issued a "not approval letter" for the drug, due to concerns about excessive sedation. This means that Lilly needs to perform additional studies before the drug can be reconsidered. This decision overrules a nonbinding recommendation issued earlier this month by FDA advisory panel that the drug should be approved despite concerns surrounding excessive sedation.

Given that the FDA usually follows the recommendation of its advisors, this news was surprising to the company and investors. Eli Lilly understandably said it was disappointed by the FDA's decision.

The drug is an alternative to Zyprexa, which is designed to ease hallucinations and other symptoms of schizophrenia. Zyprexa is already on the market in tablet form, but this new drug would allow administration only once a month.

A "not approval letter" usually means a drug is dead, but even if Eli Lilly can convince the FDA this hurdle will cause a significant delay to market.

This is all bad news for the Indianapolis-based company because though it has almost $19 billion in annual sales, this drug was predicted to add $500 million annually within two years. Long-term, a pharmaceutical company is only as good as its drug pipeline, and with Eli Lilly shares down only about 2% on the news the share price may not yet reflect the full consequences of this decision.

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