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Bioequivalency

FDA Approval

FDA approves IntelGenx’s Rizafilm for acute migraine treatment

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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In the News: October Regulatory and Development Updates

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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The Regulatory Pathway for Generic Drugs Explained

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

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When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada

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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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

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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Biogen Announces FDA Approval of Plegridy (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis

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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Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Worldwide Clinical Trials

MAY 30, 2024

Initial approval in 2022: FDA, U.S. Approval has been based on bioequivalence with the FDA stating that the effectiveness of Radicava ORS is based on a study showing comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava.

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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.

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Teva to Present New Data on Once-Daily AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets at the 2023 American Academy of Neurology Annual Meeting

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.

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FDA Knows Its Own Strength—and It Includes Concentration

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 Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Delveinsight

FEBRUARY 5, 2021

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Some of these approved products contain nicotine as an active ingredient, while others do not. Two doses, bupropion XL 15 mg and bupropion XL 300 were approved. Quitting smoking is an arduous, exhausting process.

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SKYRIZI® (risankizumab-rzaa) Now Available in the U.S. as a Single 150 mg Injection for Adults with Moderate to Severe Plaque Psoriasis

The Pharma Data

AUGUST 9, 2021

Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. ” The U.S.

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Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

JANUARY 7, 2025

They’re designed to be bioequivalent, meaning they have the same dosage, strength, route of administration, quality, and intended use as the original brand-name drug. For example, instead of saying “bioequivalent,” you might say “works the same way in the body.” What Are Generic Drugs?

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FDA approves IntelGenx’s Rizafilm for acute migraine treatment

In the News: October Regulatory and Development Updates

Webinars

Trending Sources

The Regulatory Pathway for Generic Drugs Explained

Webinars

When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Biogen Announces FDA Approval of Plegridy (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis

Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

Teva to Present New Data on Once-Daily AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets at the 2023 American Academy of Neurology Annual Meeting

FDA Knows Its Own Strength—and It Includes Concentration

The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

SKYRIZI® (risankizumab-rzaa) Now Available in the U.S. as a Single 150 mg Injection for Adults with Moderate to Severe Plaque Psoriasis

Educating Patients about Generic Drugs: Strategies for Success

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