Emergent Biosolutions Inc.; Withdrawal of Approval of a Supplemental New Drug Application for NARCAN (Naloxone Hydrochloride) Nasal Spray, 2 Milligrams/0.1 Milliliter

Resumo

The Food and Drug Administration (FDA or Agency) is withdrawing the approval of a supplemental new drug application (sNDA) for NARCAN (naloxone hydrochloride) nasal spray, 2 milligrams (mg)/0.1 milliliter (mL), held by Emergent Biosolutions Inc., 400 Professional Dr., Suite 400, Gaithersburg, MD 20879. Emergent Biosolutions, Inc., has notified the Agency in writing that NARCAN (naloxone hydrochloride) nasal spray, 2 mg/0.1 mL, is not marketed and has requested that approval of the sNDA be withdrawn. This action has no impact on the continued approval and marketing of NARCAN (naloxone hydrochloride) nasal spray, 4 mg/0.1 mL.