BioSante Pharmaceuticals, Inc. (BPAX)

[Just the facts maam]

Check out the wording in the FDA NDA approval letter for Bio-t-gel sent to Teva

Dear Mr. Vincent:
Please refer to your New Drug Application (NDA) dated January 13, 2011, received January 14, 2011, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for testosterone gel.

We acknowledge receipt of your amendments dated January 28, March 25, April 21, 22, and 27, May 2 (2), 19, and 26, June 13, July 29, August 16, September 14, 15, and 28, November 4, December 5, 2011, January 30, February 1, 10, and 13 (3), 2012.

This NDA provides for the use of testosterone gel for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.

We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of prescribing information. This waiver applies to all future supplements containing revised labeling unless we notify you otherwise.

Approval letter

Now put that into the context of the Patent issued for Libigel Dec 25, 2012.

What is claimed is:

1. A method for providing testosterone replacement therapy to a female in need thereof, which method comprises the daily and precise administering to a female of between 200 to 240 mg of a formulation that includes about 1% testosterone, an alkanol in an amount between about 5 to 80%, a polyalcohol in an amount between about 1% to 30%, and a permeation enhancer in an amount between about 1 to 30% with the formulation being substantially free of long-chain fatty alcohol, long-chain fatty acid and long-chain fatty ester compounds in order to accurately deliver between 2 to 2.4 mg of testosterone to provide an effective replacement amount of testosterone and achieve decreases in or alleviation of at least one of the clinical symptoms resulting from low testosterone levels in the female while avoiding irritation from such compounds during administration and use of the formulation.

Patent

And the Abbott "Is it low T?" campaign.