CDER Withdraws Third Product-Specific Draft Guidance in Almost 8 Years

With 1789 product-specific guidance documents published, the US Food and Drug Administration (FDA) has offered a significant amount of help to generic drugmakers looking to bring competitors to market.

On Wednesday, FDA’s Center for Drug Evaluation and Research (CDER) announced the withdrawal of just the third draft product-specific guidance since March 2012. The withdrawn guidance is meant to help with the development of generic versions of Johnson & Johnson’s pulmonary arterial hypertension drug Uptravi (selexipag), first approved in December 2015. J&J brought in $819 million in Uptravi sales in 2019 and $663 million in 2018.

The selexipag guidance was initially drafted in June 2016 and officially withdrawn last October.

FDA did not respond to a request for comment on why this particular draft was withdrawn but said in a statement to Focus: “Product-specific bioequivalence recommendations are withdrawn when they no longer reflect the Agency’s current thinking. Please refer to Guidance for Industry on Bioequivalence Recommendations for Specific Products (June 2010) for FDA’s procedures with respect to issuing product-specific bioequivalence recommendations.”

Such product-specific guidance typically provides generic drugmakers with recommendations on bioequivalence studies, what analyte to measure and other key information to help with their abbreviated new drug applications (ANDAs). But reference product sponsors often contest the methods that an ANDA applicant might use to demonstrate that a proposed generic drug is bioequivalent to the reference product (e.g., Allergan with Restasis).

But the limited number of withdrawn product-specific guidance documents goes to show how infrequently FDA decides its initial guidance needs to be updated or completely reworked.

In addition to selexipag, FDA also previously withdrew product-specific draft guidance on a levonorgestrel intrauterine system for birth control in 2014 (just six months after it was initially posted) and the fungal skin infection cream butenafine hydrochloride in 2015 (almost three years after it was posted).

Withdrawn CDER Product Specific Guidances