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 Post subject: New FDA guidance on drugs to treat alcoholism
PostPosted: Thu Feb 12, 2015 12:12 pm 
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Joined: Sat Jun 01, 2013 12:44 pm
Posts: 60
Bloomberg News reports on new FDA guidance regarding the pharmacological treatment of alcoholism, and it could be pretty consequential for the use of naltrexone and other such medications:

Quote:
Drugs to treat alcoholism can gain approval by proving patients using them no longer drink heavily, the Food and Drug Administration clarified Wednesday. The agency released draft guidelines for pharmaceutical companies wanting to develop alcoholism treatments that make clear that sobriety doesn’t have to be the main goal.


While I'm on the subject, FDA is also reconsidering allowing the makers of generic products to update the product labeling. One of naltrexone's problems has been that the label contains a good deal of inaccurate information that precludes effective promotion or education by marketers; this might be the first step toward a remedy for that situation.


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 Post subject: Re: New FDA guidance on drugs to treat alcoholism
PostPosted: Fri Feb 13, 2015 9:13 am 
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Joined: Sat Oct 18, 2014 5:36 pm
Posts: 383
Location: USA
That's good news on both counts!

At this point there's no excuse for not revising the label for naltrexone.


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