Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

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Development Bioequivalency Generic Drugs Production 242

Pharmacy Checkers

FEBRUARY 14, 2020

In fact, they asked ConsumerLab.com, sister company to PharmacyChecker, to test the product. Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. Despite the small but mighty uproar on lack of true generic equivalence, this is the case with Wellbutrin. So, the Graedons spoke up!

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Branding FDA Approval Pharmacy Bioequivalency 62

FDA Law Blog

FEBRUARY 26, 2024

Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R. mg/mL) for liquid parenteral drug products. mg/mL) for liquid parenteral drug products. FDA explained that its bioequivalence regulations at 21 C.F.R.

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Production Bioequivalency Drugs Containment 59

The Pharma Data

DECEMBER 28, 2020

Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Glucagon for Injection Emergency Kit, 1 mg. This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.”

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Bioequivalency Production Sales Marketing 52

Delveinsight

FEBRUARY 5, 2021

This means that the companies generating revenue out of their tobacco products are affluent enough to collectively spend USD 1 million every hour on advertising their products. Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Generics in the Market.

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Marketing FDA Approval Branding Production 52