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  • Draft Guidance for Nitroglycerin, Rifaximin Products Released by FDA

    The US Food and Drug Administration (FDA) released new draft guidance documents on 13 February covering rifaximin tablets, nitroglycerin metered spray/sublingual products and nitroglycerin metered aerosol/sublingual products. The draft guidances cover bioequivalence (BE) recommendations for both nitroglycerin and rifaximin products, particularly BE testing used to support Abbreviated New Drug Applications (ANDAs). The draft guidances for nitroglycerin products are "rev...