FDA issues 34 new and revised product-specific guidances

Regulatory NewsRegulatory News | 18 November 2020 |  By 

In its latest quarterly release of product-specific guidances meant to promote the development of generic drugs, the US Food and Drug Administration (FDA) on Wednesday posted 13 new and 21 revised draft guidances, bringing the total number of such guidances released by the agency to 1,974.
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. So far this year, FDA has issued or revised more than 180 product-specific guidances.
Among the new and revised guidances are 11 for complex products, such as metered dose inhalers or aerosol foams, two of which FDA says were developed based on Generic Drug user Fee Amendments-funded research. FDA points out that 24 of the guidances are for products with no approved generic competition.
One of the new draft guidances provides recommendations for demonstrating bioequivalence for generic versions of Amphastar Pharmaceuticals’ Primatine Mist epinephrine metered dose inhaler (MDI).
“This is the first [product-specific guidance] PSG for an MDI product available for non-prescription over-the-counter use to temporarily relieve mild symptoms of asthma in adults and children 12 years of age and older,” FDA says. Within the guidance, FDA recommends that generic sponsors conduct five different types of in vitro bioequivalence studies, as well as pharmacokinetic bioequivalence and comparative clinical pharmacodynamic studies to support an abbreviated new drug application (ANDA).
The agency also released a new draft guidance for generic versions of Boehringer Ingelheim’s Spiriva Handihaler (tiotropium bromide), which is used to treat bronchospasm caused by chronic obstructive pulmonary disease (COPD). FDA says it will consider comments on the draft guidance before responding to a 2012 citizen petition filed by Boehringer that calls for the agency to apply “strict requirements” to ANDAs referencing Spiriva or any of the company’s other tiotropium products.


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