GSK gains approval of sNDA for Rx Veramyst (fluticasone furoate/spray) to be marketed OTC as Flonase Sensimist, an extension of the Flonase Allergy Relief.
Fluticasone furoate will reach the US OTC market as Flonase Sensimist Allergy Relief following FDA's recent FDA approval of GlaxoSmithKline PLC's supplemental new drug application to market its previously Rx product Veramyst (fluticasone furoate/0.0275mg metered spray) over-the counter.
Flonase Sensimist is planned for a 2017 first-quarter launch in the US and Puerto Rico by GlaxoSmithKline Consumer Healthcare...
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
