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
314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” mg/mL) for liquid parenteral drug products. FDA borrowed this definition from 21 C.F.R.
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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?
Drug Channels
MARCH 15, 2022
Twice a year, I research and write two comprehensive, fact-based, and nonpartisan reports on drug channel economics. The 12 chapters are self-contained and do not need to be read in order. In some small way, I try to make the world a better and smarter place.
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.
FDA Law Blog
MARCH 13, 2024
156(d)(l)(D) requires that a PTE application contain “a brief description of the activities undertaken by the applicant during the applicable regulatory review period with respect to the approved product and the significant dates applicable to such activities” In addition, 35 U.S.C. § exclusively licensed U.S. and OPKO Ireland Ltd.
Druggist
OCTOBER 13, 2020
Truvada (emtricitabine/tenofovir disoproxil) is an antiviral drug used in the treatment of HIV, alone or as part of antiviral combination therapy. Truvada is also licensed as pre-exposure prophylaxis (PrEP) medication. This post will cover the use of Truvada and its generic form for PrEP. Today, I am reviewing Truvada for PrEP.
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