Containment 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
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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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the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).
Druggist
SEPTEMBER 30, 2020
Mebeverine, on the other hand, is a generic name of the drug, which is also known as Colofac (brand name). Both products contain the same active ingredients regardless of whether they are prescribed or purchased over the counter: Each Buscopan tablets contains 10mg of hyoscine butylbromide.
Drug Discovery World
MARCH 29, 2023
Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. However, stakeholders should be aware that the leaked review contains no such analysis. They said: “This assertion raises some difficult questions.
Druggist
MARCH 17, 2021
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. Although licensed for acne, minocycline is rarely prescribed in the UK. Over the counter products for the treatment of acne.
Druggist
MARCH 25, 2021
Do generic, and branded drugs produce exactly the same effect? . Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). In terms of prescribing, both contraceptives are regarded as the same drug. . Cerelle vs Cerazette: are they the same?
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