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Biotech / Medical : Zonagen (zona) - good buy?
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To: Dauntless who wrote (5190)8/11/1998 12:51:00 PM
From: biodoc  Read Replies (1) of 7041
 
No one can know what the Vasomax package insert will contain at this time. The final package insert is negotiated by the sponsor and the FDA at the time of approval. First, the FDA has to accept the application (which may or may not happen--I believe they have 60 days from submission to notify the company if it is not acceptable)and then approve it.

Certainly the total experience with phentolamiine will be included in any determination of the insert. Given the experience with Viagra, I can't imagine the FDA not putting a strong warning in the label unless Zonagen has EXTENSIVE safety data for people with the previously mentioned conditions, and I believe they would also specifically warn about nitrates in the absence of significant data in folks who had used them within 24 hours of vasomax.

This label issue is minor compared to the uncertainty surrounding acceptance of the application and ultimate approval.
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