Amphastar pharmaceuticals receives fda approval for dextrose injection

Rancho cucamonga, calif., march 29, 2021 (globe newswire) -- amphastar pharmaceuticals, inc. (nasdaq: amph) announced that the u.s. food and drug administration (“fda”) approved the company's abbreviated new drug application (“anda”) for dextrose injection 50% in the 50 ml luer-jet® prefilled syringe system. for the past 40 years, the company has sold and marketed the product under the “grandfather” exception to the fda's “prescription drug wrap-up” program. net revenues for the company's dextrose injection for the year ended december 31, 2020, were $7.6 million.
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