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22 MARKET NEWS
FDA approvals in the US Abbott has received approval for transmucosal
fentanyl, not long after its recommendation [see lnpharma 904: 23, II Sep 1993]. The new fentanyl product [Oralet®] is a solid lozenge mounted on a handle, and it is indicated for anaesthetic premedication in children and adults, and for use in anaesthesia or monitored anaesthesia care.
Oralet® has similar effects to 1M fentanyl and is a Schedule II controlled substance. Labelling will carry a black box warning that Oralet® is associated with a risk of hypoventilation and should be administered in a monitored setting by persons trained in the use of anaesthetic drugs. Abbott licensed Oralet® from Anesta Corporation.
An antibacterial combination of piperacillin + tazobactam [Zosyn®] has also been cleared for marketing by the FDA. The penicillinll3-lactamase inhibitor combination has been approved for the treatment of appendicitis, skin and skin structure infection, postpartum endometriosis and community-acquired pneumonia. Lederle licensed Zosyn® from Taiho Pharmaceuticals, and it will be copromoted by Medimmune.
6 Nov 1993INPHARMAe
8002J1413
ISSN 0156-2703'93'1106-00221$1.00° AdlslnternatJonal Ltd
