FDA Approval Generic Drugs Licensing Production 
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.
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. mL) in addition to Original Concentration Humira.”
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pharmaphorum
MARCH 16, 2022
Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. Generics of Symbicort are already available in some non-US markets, including in Europe.
Pharmacy Checkers
JANUARY 10, 2020
This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. That word “same” is hard to answer when it comes to prescription drugs. Is it counterfeit?
FDA Law Blog
MARCH 13, 2024
156 for certain FDA-regulated products, we know what you were thinking. Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).
XTalks
AUGUST 2, 2023
Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.
FDA Law Blog
JULY 13, 2022
As we explained last year, the Act proposes to amend Title XI of the Social Security Act to require that HHS establish a “Drug Price Negotiation Program” to “negotiate and, if applicable, renegotiate maximum fair prices” for certain single-source drugs and biological products. Each product is limited to two years of delay.
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