Roche: FDA accepts influenza drug application
(CercleFinance.com) - Roche said that the US health regulator has accepted for review the marketing application of a treatment of influenza in children.
The Food and Drug Administration (FDA) has accepted a new drug application for Xofluza, as well as two supplemental filings, the Swiss drugmaker said.
Roche is seeking approval of a new formulation of Xofluza as one-dose granules for oral suspension that offers a more convenient option for children and people who have difficulty swallowing.
The pharmaceutical company is also seeking approval for Xofluza in the treatment of acute influenza in healthy children from one to 12 years old, who have been symptomatic for less than 48 hours.
The FDA has also accepted a filing for post-exposure prophylaxis of influenza in infants of one year old and above.
The US regulator is expected to make a decision on approval in November.
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