Chiroscience Chirocaine Labeling Cites Possible Safety Advantage
Approved labeling for Chiroscience's long-acting local anesthetic Chirocaine (levobupivacaine) indicates a possible cardiac and central nervous system safety advantage over bupivacaine based on animal data.
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Celltech Chiroscience Chirocaine (levobupivacaine) Phase IV commitments include the completion of a cardiovascular resuscitation study in dogs. Chirocaine, which cleared FDA August 5 with an indication for surgical anesthesia and pain management in adults, was deemed "approvable" in February.
Zeneca will have to sell its Chiroscience shares under a Federal Trade Commission consent agreement that will allow the company to merge with Astra.
A safety comparison between Chiroscience/Zeneca's Chirocaine (levobupivacaine) and bupivacaine may depend on resuscitation data, FDA's Anesthetic & Life Support Drugs Advisory Committee members indicated Jan 12.