Advertisement Aptalis Pharmaceutical Technologies Announces European Commission Approval for a New Oral Granule Formulation of Viread® - Pharmaceutical Business review
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Aptalis Pharmaceutical Technologies Announces European Commission Approval for a New Oral Granule Formulation of Viread®

This authorization, which covers all 27 countries of the European Union (EU), follows the January 2012 U.S. Food and Drug Administration’s (FDA) New Drug Application (NDA) approval of Viread® oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-5. The oral powder, which utilizes Microcaps® taste-masking formulation technology, will be manufactured and supplied to Gilead by Aptalis Pharmatech, Inc. Gilead will be responsible for product commercialization.

"The FDA and European Commission approvals of the oral granule formulation of Gilead’s Viread® for use in the United States and Europe respectively, are examples of how our company’s turnkey business model differentiates our services in the drug development process. ‘

‘We leverage our breadth of capabilities, experience and expertise to provide a comprehensive resource for our partners to establish effective pathways to commercialization. To this end, we are pleased to have had the opportunity to co-develop the pediatric oral powder formulation of Viread® with Gilead using our Microcaps® proprietary technology" said John Fraher, President of AptalisPharma.