FDA releases batch of 21 product-specific guidances

Regulatory NewsRegulatory News | 19 May 2021 |  By 

The US Food and Drug Administration (FDA) on Wednesday issued 13 new and eight revised draft product-specific guidances intended to facilitate the development of generic drugs.
The guidances are intended to foster 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 (RLD). FDA’s current count of product-specific guidances sits at 1,896 with this latest release.
This batch of guidances covers products to treat conditions such as sickle cell disease, mantle cell lymphoma, tenosynovial giant cell tumor and schizophrenia and follows the release of 36 new and revised draft product-specific guidances in March. Earlier this month, FDA hosted a webinar focused on the use of product-specific guidances in which it noted its openness to alternative approaches to generic drug development. (RELATED: FDA issues 36 new and revised product-specific guidances, Regulatory Focus 25 March 2021; FDA welcomes alternative approaches to generic drug development, Regulatory Focus 5 May 2021).
FDA says that 16 of the product-specific guidances are for products with no approved generic versions, six of which are also complex products. In total, eight of the guidances pertain to complex products, covering RLDs such as GlaxoSmithKline’s asthma and chronic obstructive pulmonary disease (COPD) inhaler Trelegy Ellipta, UCB’s cluster seizure nasal spray Nayzilam (midazolam) and Baudax Bio’s injectable pain treatment Anjeso (meloxicam).
Among the guidances is a revised guidance for generic versions of Janssen’s interstitial cystitis drug Elmiron (pentosan polysulfate), “a complex product with complex [active pharmaceutical ingredients] APIs.” FDA says the revisions to the draft guidance “clarifies the API sameness evaluation and includes a Biopharmaceutics Classification System (BCS) 3-based biowaiver option.” (RELATED: FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers, Regulatory Focus 11 May 2021).


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