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2 medicines recalled nationwide after major label swap

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STATEN ISLAND, NY Two drugs have been recalled due to a major labeling mix-up, according to a recall notice from the U.S. Food and Drug Administration (FDA). The Harvard Drug Group, which includes Major Pharmaceutical and Rugby Laboratories, is initiating a voluntary single-lot recall of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 … Read more

FDA approves supplemental new drug application to expand Mavacamten label for hypertrophic obstructive cardiomyopathy

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The FDA has approved a supplemental new drug application (sNDA) to expand the label on mavacamten (Camzyos) to include data from the Phase 3 VALOR HCM study. The study evaluated mavacamten in patients with symptomatic hypertrophic obstructive cardiomyopathy (HCM) eligible for septal reduction therapy (SRT) and with New York Heart Association (NYHA) Class 3-4 or … Read more