Bedford Laboratories to begin shipping Dactinomycin for Injection USP 500 mcg (0.5 mg)

Bedford Laboratories™, a division of Ben Venue Laboratories, Inc., is pleased to announce the addition of Dactinomycin for Injection USP 500 mcg (0.5 mg) to its comprehensive line of generic oncology products. Dactinomycin was approved earlier this year by the U.S. Food and Drug Administration (FDA) and is AP rated and equivalent to Cosmegen® by Lundbeck Inc. Each single dose vial contains 0.5 mg (500mcg) of dactinomycin and 20 mg of mannitol and is individually boxed.

Dactinomycin, as part of a combination chemotherapy and/or multi-modality treatment regimen, is indicated for the treatment of Wilms’ tumor, childhood rhabdomyosarcoma, Ewing’s sarcoma and metastatic nonseminomatous testicular cancer. Dactinomycin is indicated as a single agent, or as part of a combination chemotherapy regimen, for the treatment of gestational trophoblastic neoplasia. Dactinomycin, as a component of regional perfusion, is indicated for the palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies.

Prescribing information is available upon request from the Bedford Laboratories’ professional services department at 800.521.5169, or from the company’s web site, www.bedfordlabs.com.

Cosmegen® is a registered trademark of Lundbeck Inc.