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.  

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