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Endo Pharmaceuticals has obtained the rights from Zars Pharma for Synera (lidocaine 70 mg/tetracaine 70 mg) topical patch. The new product was approved by the FDA in June 2005 and is used on intact skin to provide local dermal anesthesia for venous access and superficial dermatological procedures in both adults and children. Synera should be applied 20 to 30 minutes prior to the procedure and contains an oxygen-activated heating element that warms the skin in addition to providing pain relief. Synera should be commercially available in the second half of 2006.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.