Warner Chilcott gets FDA response to citizens petition

Warner Chilcott says that it has received the US Food and Drug Administration's  response to its citizen petition requesting that the  agency imposes a 30-month stay of approval on Abbreviated New Drug  Applications referencing Doryx (doxycycline) 100mg and 75mg  delayed-release tablets that were filed prior to the listing of the  product's patent under the transition rules of the QI Program Supple  mental Funding Act of 2008. In its joint-response to the citizen  petitions of the company, which sells Doryx in the USA under a licensing  deal with Australia's Mayne Pharma, and several other petitioners, the  FDA took the position that a 30-month stay would not apply to approvals  for such ANDAs.

In its response, the agency noted that, "under current law, a 30-month  stay will apply to an ANDA referencing an old antibiotic if that ANDA  contains a paragraph IV certification to a patent submitted to the [FDA]  before the ANDA was submitted, and the NDA holder or patent owner sues  the ANDA applicant for patent infringement as a result of notice of the  paragraph IV certification."