Lilly, FDA ironing out Zyprexa shot problems

Eli Lilly says it's making progress with the FDA on approval of its long-acting, injectable form of Zyprexa. You'll recall that the antipsychotic shot was up at an advisory committee recently, and panelists questioned the med's propensity to cause extreme drowsiness in some patients. The FDA ended up rejecting the formulation, saying it needed more data on the risk of and causes of that excessive sedation, which showed up in about 1 percent of patients. Well, CEO John Lechleiter (photo [1]) now says that recent meetings with the FDA have borne fruit, and the company now expects to be able to sell injectable Zyprexa "in the near future."

- read the item [2] at PharmaGossip

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