The batch of new product specific guidances published by the FDA in November 2020 include guidances for generic OINDPs referencing Valtoco diazepam nasal spray, Primatene Mist epinephrine MDI, and Spiriva Respimat tiotropium bromide SMI.
The agency approved Valtoco for the treatment of seizure clusters in January 2020. After a lengthy effort to reformulate Primatene Mist with an HFA propellant, the MDI was approved for OTC sales for the treatment of mild asthma in November 2018. Spiriva Respimat has been approved for the treatment of COPD since September 2014 and for asthma since 2015. The new guidance for tiotropium bromide is for generics referencing the 2015 NDA.
The November 2020 list of newly revised product specific guidances did not include any OINDPs.
