Bioequivalency, FDA Approval, Generic Drugs and Sales

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In the News: October Regulatory and Development Updates

Camargo

NOVEMBER 11, 2020

In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

Development

Development Bioequivalency Generic Drugs Production

Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. ” According to IQVIA, the U.S. ” According to IQVIA, the U.S.

Bioequivalency

Bioequivalency Production Sales Marketing

Clinical Research Informer

In the News: October Regulatory and Development Updates

Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

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