The FDA has issued product-specific recommendations for demonstrating the bioequivalence of over 40 drug products, including several OINDPs. The newly added documents include guidances for azelastine HCL/fluticasone propionate nasal spray, budesonide/formoterol fumarate MDI, and levalbuterol tartrate MDI.
Comments on the new guidances can be submitted to the FDA Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. The announcement refers anyone who wants to submit electronic comments to http://www.regulations.gov.
Read the guidance on azelastine HCL/fluticasone propionate nasal spray.
