The following excerpt from the patent application confirms this
[0006] In the United States, no FDA-approved testosterone therapies are available for the treatment of hypoactive sexual desire disorder (HSDD) in women although in 2009, according to IMS data and independent market research more than 4 million testosterone prescriptions were written "off-label" for women. The unapproved testosterone formulations currently used to treat women have disadvantages. Proper administration, dosing, and daily compliance are a concern when using products for unapproved uses. For example, compounding pharmacies do not follow cGMP processes that are mandated by the FDA for commercial production of pharmaceutical products.
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