New form of fentanyl given agency nod
The first buccal tablet form of fentanyl was recently given the green light by the FDA, according to manufacturer Cephalon Inc.
The first buccal tablet form of fentanyl was recently given the green light by the FDA, according to manufacturer Cephalon Inc. Fentora is indicated for the management of breakthrough pain in patients with cancer who are already receiving or are intolerant to opioid therapy for their underlying persistent cancer pain. The sugar-free tablets utilize Cephalon's proprietary OraVescent drug delivery system and are placed between the upper cheek and gum above a rear molar tooth. According to Cephalon, the tablet releases carbon dioxide when it comes in contact with saliva, leading to changes in pH to optimize drug absorption through the mucosa. Fentora will be available in five dosage strengths: 100, 200, 400, 600, and 800 cg in packages of 28 tablets.
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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.
