Determination That MEKINIST (Trametinib Dimethyl Sulfoxide) Tablets, 1 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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(FDA or the Agency) has determined that MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 milligram (mg), was not withdrawn from sale for reasons of safety or effectiveness.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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