Product-Specific Guidance for Olodaterol Hydrochloride; Tiotropium Bromide; Draft Guidance for Industry; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide." The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for olodaterol hydrochloride; tiotropium bromide inhalation spray.
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