Par Pharmaceutical Approved for Generic Vesanoid

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Par Pharmaceutical announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Tretinoin Capsules, the generic version of Roche's Vesanoid.

Vesanoid, a retinoid, is indicated in the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated.

Tretinoin Capsules will be available in 10mg dosage strength capsules, and Par expects to begin shipping the product before the end of the month.  

For more information call (800) 828-9393 or visit www.parpharm.com.

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