Approved Drug Products with Therapeutic Equivalence Evaluations ...
WEBOct 13, 2023 · Search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number.
FTC Issues Policy Statement on Brand Pharmaceutical …
WEBSep 14, 2023 · The Federal Trade Commission today issued a policy statement, supported by the U.S. Food and Drug Administration (FDA), warning pharmaceutical companies that make and sell brand-name drugs that they could face legal action if they improperly list patents in the FDA’s catalog of “Approved Drug Products with Therapeutic Equivalence ...
FDA approves selpercatinib for medullary thyroid cancer
WEB5 days ago · News and Events; Training and Continuing Education ... Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description ... Approved Drug Products with Therapeutic ...
FTC Challenges More Than 100 Patents as Improperly Listed in the …
WEBNov 7, 2023 · Today, the Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations ...
FDA is changing the therapeutic equivalence rating for Accord ...
WEBSep 18, 2023 · As a result of its review of this new information, FDA has changed the therapeutic equivalence rating for Accord Healthcare Inc.’s tacrolimus oral capsules from AB to BX.
FTC Files Amicus Brief in Asthma Inhaler Patent Dispute
WEBMar 22, 2024 · Since Teva listed those patents on its ProAir HFA inhaler in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book,” Teva’s patent infringement claims triggered a statutory stay that blocks approval of Amneal’s competing drug …
FDA Moves Generic Dapagliflozin a Step Closer to US Sales - Medscape
WEBFeb 23, 2022 · The US Food and Drug Administration (FDA), on February 23, finalized its decision approving the therapeutic equivalence of a generic formulation of the SGLT2 inhibitor dapagliflozin made by...
Approved Drug Products with Therapeutic Equivalence Evaluations
WEBApproved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and …
FTC Ramps Up Efforts to Crackdown on Inaccurate Patent
WEBMay 1, 2024 · The move targets over 300 listings for 20 branded products from companies such as AstraZeneca, Novo Nordisk, and GSK that the agency said inhibits the generic drug market.
Approved Drug Products with Therapeutic Equivalence Evaluations
WEBThe FDA produces "Approved Drug Products with Therapeutic Equivalence Evaluations", commonly referred to as the Orange Book. The Orange Book "identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).
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