Neurocrine Receives Good and Bad News for indiplon Capsules and Tablets
Back in mid-May, Neurocrine Bioscience received both good and bad news from the FDA regarding their insomnia medication Indiplon.
The capsules were approved, but the tablets were not. The capsules were a lower dose (5 and 10 mg) whereas the tablets were 15 mg. It was also interesting that the FDA admitted to not having time to review all of the information submitted in the new drug application (NDA). Although not specified, I certainly hope that the reason for not approving the 15 mg tablets was simply because they hadn’t reviewed that data. If this is the case, it is good to see the FDA go ahead and send the approvable letter for the capsules and not hold those up.
Neurocrine has listed on their web page the webcast response to the FDA letter but it appears to no longer be available. It will be interesting to see how the insomnia market share will develop since their have been several recent entrants in this area such as Lunesta and the Ambien (which has been around for quite some time). I personally have used Ambien and it works well for me, especially for dealing with jet lag when traveling to Europe on business.
Technorati Tags: FDA, Indiplon, Neurocrine
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