1. Generics Bulletin

FDA revises a guide on two inhaler types

A revised draft guidance on metered-dose inhalers (MDIs) and dry powder inhalers (DPIs), offering recommendations on chemistry, manufacturing, and controls (CMC) information to be included in abbreviated new drug applications (ANDAs), as well as new drug applications (NDAs), has been published by the US Food and Drug Administration (FDA). The 46-page guidance document updates previous draft guidance from November 1998, reflecting current standards and requirements for development approaches for MDIs and DPIs, consistent with the FDA’s ‘quality by design’ (QbD) paradigm.

A revised draft guidance on metered-dose inhalers (MDIs) and dry powder inhalers (DPIs), offering recommendations on chemistry, manufacturing, and controls (CMC) information to be included in abbreviated new drug applications (ANDAs), as well as new drug applications (NDAs), has been published by the US Food and Drug Administration (FDA). The 46-page guidance document updates previous draft guidance from November 1998, reflecting current standards and requirements for development approaches for MDIs and DPIs, consistent with the FDA’s ‘quality by design’ (QbD) paradigm.

Several blockbuster respiratory brands in the US, including GlaxoSmithKline’s (GSK’s) Advair (fluticasone/salmeterol) and AstraZeneca’s Symbicort (budesonide/formoterol), currently have a monopoly on the market, with no approved ANDA products.

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