Determination That MEKINIST (Trametinib Dimethyl Sulfoxide) Tablets, 1 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or the Agency) has determined that MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 milligram (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for trametinib dimethyl sulfoxide tablets, 1 mg, if all other legal and regulatory requirements are met.
Abstract as published in the Federal Register.
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