21st Dec 2019 11:40
(Alliance News) - ViiV Healthcare said Saturday it has received a complete response letter from the US Food & Drug Administration related to its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.
The FDA sends a complete response letter if it determines to not approve a new drug application in its current form.
ViiV, a joint venture of GlaxoSmithKline PLC, Pfizer Inc and Shionogi Ltd, said the reasons given by the FDA for its rejection relate to chemistry manufacturing and controls, rather than any safety issues. It said it will work with the US regulator to determine next steps for the application.
By Tom Waite; [email protected]
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