Roche: FDA accepts new filing for influenza drug
(CercleFinance.com) - Roche said on Wednesday that the US Food and Drug Administration had accepted to review the filing of a new drug application for its influenza drug Xofluza.
The FDA has accepted a supplemental new drug application (sNDA) for people at high risk of complications, adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, obesity or heart disease, the Swiss drugmaker said.
The FDA is expected to make a decision regarding the drug's approval by 4 November, Roche said.
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The FDA has accepted a supplemental new drug application (sNDA) for people at high risk of complications, adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, obesity or heart disease, the Swiss drugmaker said.
The FDA is expected to make a decision regarding the drug's approval by 4 November, Roche said.
Copyright (c) 2019 CercleFinance.com. All rights reserved.