FDA Issues 43 Product-Specific Guidances for Generic Drugs

Regulatory NewsRegulatory News | 02 March 2020 |  By 

Editor’s note: This article has been updated to note that FDA issued a revised draft product-specific guidance for a drug after the agency withdrew the previous version of the guidance last month.

The US Food and Drug Administration (FDA) on Monday released a batch of 43 new and revised draft product-specific guidances to support the development of generic drugs.
The guidances, when finalized, are intended to promote generic competition by clarifying FDA’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far, FDA has issued a total of 1,832 product-specific guidances.
This latest batch features 33 new and 10 revised draft product-specific guidances and comes more than three months after the agency’s last batch.

Notably, FDA re-issued and revised its draft guidance for developing generic versions of Johnson & Johnson’s pulmonary arterial hypertension drug Uptravi (selexipag), which the agency withdrew last month.
The new draft guidances include recommendations for conducting bioequivalence studies to support the approval of generic versions of AbbVie’s rheumatoid arthritis drug Rinvoq (upadacitinib) and for obtaining in vivo bioequivalence study waivers for generic versions of Novo Nordisk’s type 2 diabetes drug Ozempic (semaglutide).
Among the revised draft guidances are five that provide recommendations for complex generics delivered via metered dose inhalers or sprays, including aerosol and powdered albuterol sulfate inhalers and calcitonin salmon nasal spray.
In addition to the release of the new and revised draft guidances, FDA also updated its list of planned product-specific guidances for complex generics for the coming year.
Federal Register Notice, Product-Specific Guidances


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