STAT

MAY 14, 2024

At the time, the Food and Drug Administration required Amgen to run a trial confirming earlier test results, as well as a so-called post-marketing study to examine safety and effectiveness at different dosages, in order to gain full approval. Continue to STAT+ to read the full story…

Dosage 141

Dosage FDA 141

The Checkup by Singlecare

AUGUST 29, 2023

Food and Drug Administration (FDA) in 2012 as a brand-name drug. Although a generic was approved in 2019, generic apixaban will not be available on the market until at least April 2028. The FDA approved two applications for generic versions of Eliquis by the companies Micro Labs Limited and Mylan Pharmaceuticals, Inc.

Dosage 52

Dosage Labelling Insurance FDA 52

The FDA Law Blog

JANUARY 18, 2023

The topics focus on issues relevant in the first three years of the Negotiation Program—2026 to 2028. Method for applying the MFP across different dosage forms and strengths of a selected drug. Upcoming CMS Guidance CMS provides a list of topics on which it plans to issue guidance.

Dosage 59

Dosage 59