The FDA has announced on the Federal Register (FR) prepublication page the availability (tomorrow) and publication of two documents that will be of significant interest to the industry.

The first is a draft guidance entitled Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate.   The reference listed drug is Advair Diskus, a popular drug used for breathing disorders, including asthma and COPD.  Industry has been waiting for direction on the requirements for establishing bioequivalence of this product for a generic for this complex product.  Advair Diskus is a powder for oral inhalation and represents a class of inhaled product for which the FDA has not yet approved a generic.  Two key issues that have been the subject of much debate relate to the unique device of the RLD and the general question of how one establishes bioequivalence.  In its FR notice, the FDA acknowledges that the innovator, GSK, has a pending petition (submitted December 2009 Docket No. FDA-2009-P-0597 (here) asking that no abbreviated new drug application (ANDA) or 505(b)(2) new drug application (NDA) be approved unless certain conditions are  met, including issues related to the data that must be generated to establish bioequivalence.  The FDA has indicated that it would like to consider public comment on its draft guidance prior to responding to the GSK petition.  The FR notice can be found here. The second document we will look for tomorrow is Revision 1 to the August 27, 2012 document entitled Generic Drug User Fee Amendments of 2012: Questions and Answers.  The FDA has evaluated the comments received to that guidance, as well as new questions that have arisen since that guidance, and has clarified certain responses based on those comments and provided responses to some of the new questions.  The FR notice can be found here.

We will review these two documents when they publish tomorrow and will provide appropriate commentary relative to their contents, so please check back tomorrow afternoon.

Questions on these topics should be addressed to the Lachman Regulatory staff by contacting Joan Janulis, VP of Regulatory, at