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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list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
Since 1997, United States law has declared a list of bio-agents designated by the U.S. Department of Health and Human Services or the U.S. Department of Agriculture that have the "potential to pose a severe threat to public health and safety" to be officially defined as "select agents" and possession or transportation of them are tightly controlled as such. [5]
Under United States law, Biological select agents or toxins (BSATs)—or simply select agents for short—are bio-agents which (since 1997 [1]) have been declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the "potential to pose a severe threat to public health and safety".
Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products (generic drugs).
In 1997, United States law formally defined weaponizable bio-agents as "Biological Select Agents or Toxins" (BSATs) — or simply Select Agents for short [24] — which fall under the oversight of either the U.S. Department of Health and Human Services or the U.S. Department of Agriculture (or both) and which have the "potential to pose a ...
The USDA animal safety list is located at 9 CFR Subchapter B. [4] Not all select agents require BSL-4 handling, namely select bacteria and toxins, but most select agent viruses do (with the notable exception of SARS-CoV-1 which can be handled in BSL3). Many non-select agent viruses are often handled in BSL-4 according to facility SOPs or when ...
1.09 Alkylating agents: Altretamine: PO Alkylates DNA. Recurrent or advanced ovarian cancer Myelosuppression, peripheral neuropathy, seizures and hepatotoxicity (rare). Bendamustine: IV: Alkylates DNA. Chronic lymphocytic leukaemia, mantle cell lymphoma and non-Hodgkin's lymphoma. Myelosuppression, hypokalaemia and tachycardia. Busulfan: IV, PO ...
Alipogene tiparvovec (Glybera): AAV-based treatment for lipoprotein lipase deficiency (no longer commercially available); Axicabtagene ciloleucel (Yescarta): treatment for large B-cell lymphoma [1]