Zdrowie i gospodarka · 7.12.2010
Determination That GLEEVEC (Imatinib Mesylate) Capsules, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that GLEEVEC (imatinib mesylate) Capsules, 50 milligrams (mg) and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for imatinib mesylate capsules, 50 mg and 100 mg, if all other legal and regulatory requirements are met.