By CHERYL A. THOMPSON / http://www.ashp.org
BETHESDA, MD, With all three domestic manufacturers of cytarabine injection having trouble making the antineoplastic, FDA said it is exploring all options to address the shortage of this critical drug product.
One of these options is importation, an agency spokeswoman said today, adding that more details will be provided if and when a plan is finalized.
FDA in the past year has turned to importation from Europe to improve domestic supplies of at least two drug products: ethiodized oil injection (PDF) and levoleucovorin powder for injection (PDF).
In the case of ethiodized oil injection, the product comes from a French company whose manufacturing facility complies with European good manufacturing practice regulations.
The levoleucovorin product comes from an FDA-inspected facility in Italy.
Neither product, according to the importers, is entirely identical to. the U.S. version.
According to the March 8 ASHP drug shortage bulletin on cytarabine, Hospira on March 7 told the University of Utah's Drug Information Service that all of the company's cytarabine is on back order. But the company said it expects to release 1-g, 500-mg, and 100-mg vials in the middle or latter part of March and 2-g vials in the middle of the second quarter of 2011.
Likewise, APP Pharmaceuticals Inc. and Bedford Laboratories told Utah that all of their cytarabine is on back order.
APP on February 17 told Utah that the company expects to release 2-g vials in the second quarter of 2011. Bedford on March 8 said it could not estimate a date for releasing any cytarabine vials
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