FDA Updates List of Drugs Without Generic Competition

Regulatory NewsRegulatory News | 26 June 2018 |  By 

For the second time since releasing its list of off-patent, off-exclusivity drugs without an approved generic competitor last year, the US Food and Drug Administration (FDA) on Tuesday updated the list to include new products.

The document includes two lists, one containing drugs that FDA could immediately accept an abbreviated new drug application (ANDA) for without prior discussion, and another that lists drugs with potential legal, regulatory or scientific issues that would need to be address prior to ANDA submission.

In December FDA updated the list for the first time, adding new drugs and reorganizing the list based on drug product rather than by active ingredients. The agency also added information about the dosage form for each product.

With the latest update, FDA says it has added new products to the list as well as an appendix listing drugs that have fallen off the list as new ANDAs for those products have been approved.

The appendix currently lists 11 drugs that previously did not have an approved generic despite the expiry of the reference product's patents and exclusivity, including an injectable dosage form of the muscle relaxant baclofen and the antidepressant fluoxetine hydrochloride in tablet form.

FDA says it will continue to update the list every six months "to ensure continued transparency regarding drug products where increased competition has the potential to provide significant benefit to patients."

While the agency has billed the list as a way of encouraging the development of generics for drugs that are no longer protected from competition, Rachel Schwartz, director of communications for the Association for Accessible Medicines told Focus that many of the products on the list "are likely not candidates for generic engagement because of the specialty nature of the products."

According to Schwartz, the main barrier to developing generics for those products is manufacturing related, as more complex products "require specialty manufacturing processes and facilities" that many generic drug manufacturers do not currently possess.



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