Back in March 2018, we posted a blog that outlined the FDA actions to remove ANDAs for prescription PEG 3500 (brand Miralax) after a complete RX to OTC switch by the innovator was made. That post can be found here. The story is complex, and it took over 11 years to unfold, so if you are interested please see the post and the embedded link to the Federal Register (FR) Notice that put forth the FDA’s decision to deny the notice of opportunity for hearing by the ANDA holders of the Rx labeled versions of PEG 3500 and withdraw the ANDAs.
Today in the FR, the FDA has announced a temporary stay of the withdrawal of the ANDAs until November 2, 2018 (previously the stay was to end on April 2, 2018). The extra 6-month stay is to give time for the Rx manufacturers to deplete their existing supplies although it is unclear if they can continue to manufacture additional supplies during this window. The FR notice temporarily extending the stay can be found here.
This means that the Rx version can continue to be sold until the November 2nd date and that insurance companies will likely continue to pay for those prescriptions. After November, patients will need to head to their local OTC outlet to obtain “relief”.