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.

FDA Approval 246

FDA Approval Bioequivalency Marketing Manufacturing 246

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.

Development 242

Development Bioequivalency Generic Drugs Production 242

Drug Patent Watch

JANUARY 22, 2025

They must file an Abbreviated New Drug Application (ANDA) with the FDA, which includes a certification that the generic drug is bioequivalent to the original. The FDA then reviews the ANDA, ensuring the generic drug meets the same standards as the original. This is where generic manufacturers come into play.

Generic Drugs 40

Generic Drugs Bioequivalency Drugs FDA Approval 40

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.

Branding 62

Branding FDA Approval Pharmacy Bioequivalency 62

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.

Development 161

Development Production Immune Response Licensing 161

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.

Bioequivalency 52

Bioequivalency Production Sales Marketing 52

The Pharma Data

APRIL 11, 2023

Dose proportionality and bioequivalence studies demonstrate once-daily AUSTEDO XR is therapeutically equivalent to twice-daily AUSTEDO ® (deutetrabenazine) tablets The U.S. Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging.

Bioequivalency 40

Bioequivalency FDA Approval Medicine Bioavailability 40