The FDA has issued dozens of new product-specific draft guidances for generic drug development, including a draft guidance for dry powder formulations of albuterol sulfate. The guidance covers development of generic equivalents to Teva’s ProAir RespiClick, which was approved for the treatment of asthma in adults in 2015 and for pediatric use in 2016.
The draft guidance recommends two in vitro studies (single actuation content and APSD), a fasting PK study, and either a bronchodilation or bronchoprovocation PD study to establish bioequivalence. The document also lists characteristics of the reference device that should be considered in the design of the test product, including the fact that the RespiClick device is breath actuated.
Comments on the draft guidance should be submitted to the to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015.
Read the FDA draft guidance on albuterol sulfate.
