Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. Rizaport and Maxalt are different formulations of Rizatriptan benzoate.

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Pharmacy Checkers

FEBRUARY 14, 2020

Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. Several years later, the FDA ordered bioequivalence tests and finally, through those results, which found, like ConsumerLab.com did, that the People’s Pharmacy was right, and forced the drug off the market.

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The Pharma Data

FEBRUARY 1, 2021

The FDA’s approval of the IM administration for Plegridy is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. Related Articles: Plegridy (peginterferon beta-1a) FDA Approval History. percent vs. 32.1 percent).

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Camargo

NOVEMBER 11, 2020

announced a collaboration to develop a companion diagnostic for Vitrakvi® (larotrectinib) NTRK (neurotrophic tropomyosin receptor kinase) inhibitor, approved in the U.S. In October, less than 18 months later, the FDA approved the companion test, which will allow physicians to better identify target eligible patients.

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FDA Law Blog

FEBRUARY 26, 2024

FDA explained that its bioequivalence regulations at 21 C.F.R. It was not too long ago that FDA punted on BI’s petition. Boehringer’s regulatory argument got no further traction. do not help Boehringer’s case. Those regulations break “concentration” out from strength but only in certain contexts.

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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.

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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