FDA releases 81 product-specific guidances

The FDA on Thursday released product-specific guidance documents for 81 active pharmaceutical ingredients to aid generic drug development, including 28 new draft guidances and 53 revised draft guidances.

The guidances, when finalized, are intended to promote generic competition by clarifying the FDA’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far, the FDA has issued nearly 1,800 product-specific guidances.

As part of its commitments under the Generic Drug User Fee Amendments (GDUFA II) reauthorization, the FDA committed to issuing product-specific guidances for 90% of non-complex new chemical entity new drug applications (NDAs) approved after 1 October 2017 at least two years ahead of the earliest abbreviated new drug application (ANDA) filing date. The agency also committed to issuing product-specific guidances for complex products “as soon as scientific recommendations are available.”
Among the new guidances are recommendations for the studies necessary to support ANDA approvals for Viiv Healthcare’s two-drug once-daily HIV drug Juluca (dolutegravir/rilpivirine), Amicus Therapeutics’ Fabry disease drug Galafold (migalastat) and Advanced Accelerator Applications’ cancer drug Lutathera (lutetium dotatate Lu-177).

Most of the new draft guidances are for oral formulations, though a few are for ophthalmic, intravenous and subcutaneous formulations.

Most of the revised draft guidances are for topical and transdermal formulations, including extended release film formulations of estradiol, fentanyl and nicotine.

FDA releases 81 product-specific guidances