Nelson Vergel
Founder, ExcelMale.com
Perrigo Israel Pharmaceuticals is going to bat against the United States Food and Drug Administration (“FDA”) over its “failure” to announce the approval of a testosterone gel.
Perrigo's product, a generic testosterone gel 1% is bioequivalent to AbbVie's Androgel. It wasapproved January 31, 2013 by the FDA, and Perrigo claims it asked the FDA to publish its “therapeutic equivalence evaluation” (TE) ratings in the “Orange Book,” which the FDA is required to update every 30 days with drugs that are approved.
Why is the “Orange Book” important?
The Orange Book is filled with FDA-approved drug products. Staff members compiled it in October 1980. The Orange Book Search can also be found on the FDA's website, where it has been since October 31, 1997.
Perrigo filed its case on March 21st, 2014 in the United States District Court for the District of Columbia (Case 1:14-cv-00475). In the document, Perrigo claims it was and is the FDA's “duty” to update the “Orange Book.” The company claims the FDA published other TE ratings for several other drugs that had been approved “after” Perrigo's testosterone gel product.
Perrigo is asking for a “mandatory injunction” to force the FDA to publish a TE rating for the company's product.
Note: We are trying to contact the company to see what their pricing is like compared to Androgel and other products approved in the US.
Perrigo's product, a generic testosterone gel 1% is bioequivalent to AbbVie's Androgel. It wasapproved January 31, 2013 by the FDA, and Perrigo claims it asked the FDA to publish its “therapeutic equivalence evaluation” (TE) ratings in the “Orange Book,” which the FDA is required to update every 30 days with drugs that are approved.
Why is the “Orange Book” important?
The Orange Book is filled with FDA-approved drug products. Staff members compiled it in October 1980. The Orange Book Search can also be found on the FDA's website, where it has been since October 31, 1997.
Perrigo filed its case on March 21st, 2014 in the United States District Court for the District of Columbia (Case 1:14-cv-00475). In the document, Perrigo claims it was and is the FDA's “duty” to update the “Orange Book.” The company claims the FDA published other TE ratings for several other drugs that had been approved “after” Perrigo's testosterone gel product.
Perrigo is asking for a “mandatory injunction” to force the FDA to publish a TE rating for the company's product.
Note: We are trying to contact the company to see what their pricing is like compared to Androgel and other products approved in the US.
