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This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
FDA-licensed in 1998; Withdrawn in EU (2002), US (2006) Fosamprenavir: HIV ViiV Healthcare: Amprenavir pro-drug: 2003 (FDA), 2004 Foscarnet: Herpes: Pyrophosphate analogue DNA polymerase inhibitor: 1991 Ganciclovir (Cytovene) [9] Cytomegalovirus (CMV) [10] Competitive nucleoside analogue dGTP inhibitor 1988 Ibacitabine: Herpes labialis ...
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this ...
Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act. Finally, the Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them.
The drugs' placement on the FDA's shortage list allowed compounders free rein to produce the copycats. But that is now coming to a halt. The FDA said these entities have about 60 days to cease ...
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