Determination That NAROPIN (Ropivacaine Hydrochloride) Solution, 50 Milligrams/10 Milliliters and 75 Milligrams/10 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that Naropin (ropivacaine hydrochloride) solution, 50 milligrams (mg)/10 milliliters (mL) and 75mg/10mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these drug products as long as they meet relevant legal and regulatory requirements.
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