Containment Drugs Generic Drugs Licensing 
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.
FDA Law Blog
FEBRUARY 26, 2024
Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”
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Druggist
SEPTEMBER 30, 2020
Buscopan and mebeverine are two common drugs used for symptomatic treatment of irritable bowel syndrome (IBS). Both drugs can be prescribed by a doctor or purchased over the counter from pharmacies and in case of Bucopa IBS relief from supermarkets. Buscopan vs Mebeverine lists similarities and differences between both drugs.
Drug Channels
MARCH 15, 2022
Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Examines Consolidation and Vertical Integration of U.S. drug pricing, reimbursement, and dispensing system. d/b/a Drug Channels Institute. The 2022 Economic Report on U.S.
FDA Law Blog
MARCH 13, 2024
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the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). exclusively licensed U.S. The PTE statute at 35 U.S.C. §
Drug Discovery World
MARCH 29, 2023
Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.
Druggist
MARCH 17, 2021
Lymecycline is a drug, which belongs to a group of tetracycline antibiotics. Lymecycline is usually prescribed as a generic drug – lymecycline 408mg capsules or occasionally as a branded medication called Tetralysal 300 mg capsules. Both drugs are the same medicines. Why is lymecycline used in the treatment of acne?
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