Anesiva Zingo gets fast-acting approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's Aug. 16 approval of the fast-acting topical local analgesic comes five weeks ahead of the NDA's Sept. 24 user fee goal. The needle-free Zingo system delivers 0.5 mg lidocaine powder into the epidermis of the skin, providing local analgesia one to three minutes after administration. Commonly used local anesthetics take 20 minutes or longer to act, Anesiva notes. Zingo is approved to reduce pain associated with venous access procedures, such as IV insertions or blood draws, in children ages 3 to 18. The company plans to file an sNDA broadening the label to include adults by the end of the year...
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