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# Actavis Wants Azacitidine AP Rating
- URL: https://www.fdaweb.com/actavis-wants-azacitidine-ap-rating/
- Published: 2016-08-11T12:00:00.000Z
- Updated: 2026-09-14T21:23:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136480

Actavis is asking FDA to assign an AP therapeutic equivalence code to its Azacitidine for Injection, 100 mg/vial, which was approved 4/29 in a 505(b)(2) NDA. The petition says that the product meets all applicable requirements for therapeutic equivalence and interchangeability with Celgene’s Vidaza (azacitidine for injection) and thus an AP code is warranted.

The company says its product is provided in a lyophilized powder formulation that must be reconstituted with sterile water and administered via subcutaneous injection or intravenous infusion to treat several subtypes of myelodysplastic syndrome. Although the drug was originally developed as a generic version of Vidaza, the company says, due to certain formulation changes during the development process, Actavis submitted a 505(b)(2) NDA instead of an ANDA. It cited Vidaza as the reference-listed drug in its NDA, it says, and relied on FDA’s prior finding of safety and effectiveness for Vidaza.

“Actavis’ Azacitidine for Injection provides the same active ingredient as Vidaza in the same strength, dosage form, and route of administration,” the petition says. “Actavis’ product is also bioequivalent to Vidaza based on *in vitro* dissolution testing data submitted in Actavis’ 505(b)(2) NDA. The only difference between the two products is inactive ingredients.”