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Status:
US Approved Rx
(2007)
Source:
ANDA065361
(2007)
Source URL:
First approved in 1999
Source:
NDA050778
Source URL:
Class:
POLYMER
Targets:
Conditions:
Epirubicin is an anthracycline cytotoxic agent, is a 4'-epi-isomer of doxorubicin. The compound is marketed by Pfizer under the trade name Ellence in the US. It is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. Although it is known that anthracyclines can interfere with a number of biochemical and biological functions within eukaryotic cells, the precise mechanisms of epirubicin’s cytotoxic and/or antiproliferative properties have not been completely elucidated. It is known, that epirubicin forms a complex with DNA by intercalation of its planar rings between nucleotide base pairs, with consequent inhibition of nucleic acid (DNA and RNA) and protein synthesis. Such intercalation triggers DNA cleavage by topoisomerase II, resulting in cytocidal activity. Epirubicin also inhibits DNA helicase activity, preventing the enzymatic separation of double-stranded DNA and interfering with replication and transcription. Epirubicin is also involved in oxidation/reduction reactions by generating cytotoxic free radicals.
Status:
US Previously Marketed
Source:
Solution of Formaldehyde U.S.P.
(1921)
Source URL:
First marketed in 1921
Source:
Solution of Formaldehyde U.S.P.
Source URL:
Class:
POLYMER
Targets:
Conditions:
Formaldehyde is a naturally occurring organic compound, and an important industrial precursor to many other materials and organic compounds. Formaldehyde solution (formalin) is used as a disinfectant. Formaldehyde vapors are toxic, upon entry formaldehyde reacts readily with macromolecules, including DNA to form DNA-protein and DNA-DNA cross-links.