The FDA has announced the publication of a batch of new and revised product specific guidances for development of generic versions of a number of drugs, including a number of inhaled and nasal drug products, .
One of the new guidances is for generic sumatriptan succinate nasal powder. Onzetra Xsail intranasal sumatriptan was approved by the FDA in January 2016 for the treatment of migraine headaches and was launched in the US in May 2016 by Avanir, which announced the termination of its license agreement with OptiNose for the product in December 2018. Onzetra Xsail is currently marketed by Currax Pharmaceuticals, which acquired the North American rights in September 2019.
The other new guidance is for umeclidinium bromide/vilanterol trifenatate inhalation powder (Anoro Ellipta). The FDA approved Anoro Ellipta for the treatment of COPD in April 2013, and GSK launched the DPI in the US in April 2014.
The revised product specific guidances are for:
- albuterol sulfate MDIs (Ventolin HFA, ProAir HFA, and Proventil HFA)
- albuterol sulfate inhalation powder (ProAir Digihaler)
- beclomethasone dipropionate MDI (Qvar 40)
- levalbuterol tartrate MDI (Xopenex HFA)
- calcitonin salmon nasal spray (Miacalcin)
Comments on the draft guidances must be submitted to the FDA by May 4, 2020.
Read the FDA notice.
