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Yuan C, Demers A, Silva-Ortiz V, Hasoon JJ, Lee W, Dave K, Amirdelfan K, Burke HW, Christo PJ, Robinson CL

If CMS determines that FDA has approved such a therapeutically equivalent drug under a 505(j) ANDA, CMS will then use the NDC Directory, including historical information from NDC Directory files such as discontinued, delisted, and expired listings provided by FDA or published on the FDA website to determine the marketing status of such therapeutically equivalent drug and to determine whether, during the applicable period, the therapeutically equivalent drug was marketed

2023 Nov 23;11(23):3026

doi: 10.1096/fj.07-8290com

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The authors reported 11 of 12 patients improved in pain