Zdrowie i gospodarka · 7.07.2010
Determination That ACTONEL (Risendronate Sodium) Tablets, 75 Milligrams, and ACTONEL WITH CALCIUM (Risendronate Sodium and Calcium Carbonate (Copackaged)) Tablets, 35 Milligrams/500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing the determination that ACTONEL (risendronate sodium) Tablets, 75 milligrams (mg), and ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate (copackaged)) Tablets, 35 mg/500 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 these products, if all other legal and regulatory requirements are met.