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# ‘Skinny Label’ Allowed Faster Generic Entry: Study
- URL: https://www.fdaweb.com/skinny-label-allowed-faster-generic-entry-study/
- Published: 2022-01-12T12:00:00.000Z
- Updated: 2026-09-14T17:28:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150919

Harvard Medical School researchers say the FDA process of allowing generic drug manufacturers to market versions with so-called skinny labels that exclude patent-protected indications allowed generic versions of Novartis’ Gleevec (imatinib) to enter the market before patent protections for treating gastrointestinal stromal tumors (GIST) expired. Writing in the *Journal of Clinical Oncology* (subscription or purchase required), the researchers [say](https://ascopubs.org/doi/full/10.1200/JCO.21.02139?ref=fdaweb.com) the generic form of Gleevec was first available in 2/2016 and the generics had labels that included indications covering treatment of chronic myelogenous leukemia and excluded treatment of GISTs because of remaining patent protections.

“Generic versions of imatinib were dispensed frequently for indications both included and excluded from the skinny labeling,” the researchers found, “although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.”