The Food and Drug Administration panel has approved Botox for various uses apart from using it as a wrinkle treatment. The FDA has also approved it for the use of eye muscle disorders and excessive underarm sweating. However, it was brought into light that physicians often use it for unapproved conditions like muscle-spasm condition. Hence, the off-label drug marketing policy by the FDA is incorrect in this context.

The lawsuit by Allergan stated that while drugs are being legally prescribed by the physicians for unapproved uses, companies are forbidden from marketing drugs, especially to physicians, for any use not approved by the FDA. So far the FDA has not commented on the pending litigation and the currently the lawsuit is filed in the U.S. District Court for the District of Columbia against the government and the FDA.

The news has definitely hurt the share prices of Allergan, but the company has remained firm on its decision and has said that this was a matter of necessity. It was in September this year when FDA instructed Allergan to implement REMS program which discusses some off-label prescribing guidelines for doctors. However, the company is not happy with the REMS program and has boldly said that this program does not serve public health. However, analysts are concerned over the penalties that government might levy on Allergan during the trial.

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The FDA gives a public target date for a NDA (New Drug Application) and other types of submissions under the PDUFA. Some sites actually try and charge you $120 or more for this FREE public information. Dont fall for the scam, this is free public information.

The biotech market is hot right now especially after VNDA’s 900% gain overnight. People are now trying to find the next hidden gem biotech stock that will multiply your investment. These dates from the FDA can be a great time to invest since the stocks can get very volitole and many times stastics are on your side. Just look at how 70%-90% of all drugs that pass Phase 3 testing and are waiting on the FDA’s NDA (New Drug Application) decision are approved.

To help you find the next big biotech stock waiting for FDA approval, we are giving away our FREE FDA Calendar today exclusively to our new forum members of the FavStock.com stock forums. Plus you can stop by our stock market forums and talk about some of the biotech stocks recently in the news such as Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), Allergan, Inc. (NYSE:AGN), Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI), and Incyte Corporation (NASDAQ:INCY)

http://www.favstocks.com/forum/

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