Source: FDA, National Drug Code (US) Revision Year: 2020
MYLERAN (busulfan) is a bifunctional alkylating agent. Busulfan is known chemically as 1,4-butanediol dimethanesulfonate and has the following structural formula:
CH3SO2O(CH2)4OSO2CH3
Busulfan is not a structural analog of the nitrogen mustards. MYLERAN is available in tablet form for oral administration. Each film-coated tablet contains 2 mg busulfan and the inactive ingredients hypromellose, lactose (anhydrous), magnesium stearate, pregelatinized starch, triacetin, and titanium dioxide.
The activity of busulfan in chronic myelogenous leukemia was first reported by D.A.G. Galton in 1953.
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MYLERAN is supplied as white, film-coated, round, biconvex tablets containing 2 mg busulfan in amber glass bottles with child-resistant closures. One side is imprinted with “GX EF3” and the other side is imprinted with an “M”. Bottle of 25 (NDC 76388-713-25). Mfd. by: EXCELLA GmbH, Feucht, Germany For: Aspen Global Incorporated, GBS Plaza, Cnr La Salette & Royal Roads, Grand Bay, Mauritius Distributed by: Prasco Laboratories, Mason, OH 45040 USA |
| Drug | Countries | |
|---|---|---|
| MYLERAN | Austria, Australia, Canada, Estonia, France, Hong Kong, Ireland, Israel, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Tunisia, United States |
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