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.

Development 242

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. Product of Canada; Manufactured by Valeant Pharmaceuticals $60.00* Product of Canada; Manufactured by Valeant Pharmaceuticals $42.90

Branding 62

Branding FDA Approval Pharmacy Bioequivalency 62

The Pharma Data

FEBRUARY 1, 2021

This approval expands Biogen’s industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of Plegridy, and follows the European Commission’s marketing authorization for the IM administration in December 2020. “At or visit your respective country’s product website. percent vs. 32.1

FDA Approval 40

FDA Approval Bioequivalency Clinical Trials Clinical Trials 40

Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. 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.

Marketing 52

Marketing FDA Approval Branding Production 52

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

Development 161

Development Production Immune Response Licensing 161

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.”

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 Bioavailability Medicine 40