Repackaged Avastin® Service
FDA compliant Repackaged Avastin From Leiters
According to a 2017 survey conducted by the American Society of Retina Specialists, ‘Global Trends in Retina’, Avastin is the most commonly used first-line drug for most retinal diseases1. Avastin must be repackaged into individual doses for ophthalmic use. In January of 2018, the FDA issued its final guidance on the repackaging of biological products. This guidance required FDA-registered outsourcing facilities to develop new methods for repackaging Avastin, a vital medication for the treatment of retinal diseases.
This Industry Bulletin describes the background behind the FDA’s action and chronicles one 503B outsourcing facility’s journey to meet the new guidance.
Leiters takes the Lead in Repackaging Avastin® for Retinal Diseases.
In an era of rapid regulatory change and heightened demand for high quality compounded and repackaged drugs, Leiters, an FDA-registered 503B outsourcer, has emerged as a leader. Specializing in ophthalmology and hospital-based services, Leiters provides repackaged Avastin in accordance with the Food and Drug Administration’s 2018 Final Guidance for the Repackaging of Biologics.
The Leiters’ Difference Makes a Difference for your Patients.
• FDA compliant
• USP <789> compliant for visible and subvisible particles
• Batch release testing for sterility, endotoxin, color and clarity, visible particles, and subvisible particles
• Repackaged in silicone-free syringe
• Repackaging process that includes an optimized aseptic technique
• cGMP compliance which ensures the biologic product maintains appropriate package integrity during shipping
Avastin® is a registered trademark of Genentech, Inc.