FDA issues 36 new and revised product-specific guidances

Regulatory NewsRegulatory News | 28 August 2020 |  By 

The US Food and Drug Administration (FDA) on Friday released its latest batch of product-specific guidances, posting 19 new and 17 revised draft guidances, bringing the total number of product-specific guidances issued by the agency to 1,938.
The guidances, which FDA posts quarterly, are intended to promote generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far this year FDA issued nearly 150 product-specific guidances. (RELATED: FDA issues 43 product-specific guidances for generic drugs, Regulatory Focus, 2 March 2020; FDA issues 69 new and revised draft product-specific guidances, Regulatory Focus 3 June 2020).
Among the newly added draft product-specific guidances are recommendations for generic versions of Novartis’ breast cancer drug Piqray (alpelisib), Janssen’s nasal spray for treating major depression Spravato (esketamine) and Loxo Oncology’s Vitrakvi (larotrectinib), which is approved to treat solid tumors with neurotrophic receptor tyrosine kinase (NTRK) gene fusions.
The revised draft guidances feature recommendations for generics of Janssen’s blood clot drug Xarelto (rivaroxaban) and several of ViiV Healthcare’s HIV treatments, including Tivicay (dolutegravir), Triumeq (abacavir/dolutegravir/lamivudine) and Juluca dolutegravir/rilpivirine).


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