ROCKVILLE, Md. -- The FDA today approved Omnaris (ciclesonide), a corticosteroid nasal spray, for hay fever symptoms in adults and children 12 years of age and older.
ROCKVILLE, Md., Oct. 23 -- The FDA today approved Omnaris (ciclesonide), a corticosteroid nasal spray, for hay fever symptoms in adults and children 12 and older.
The agency said the precise way Omnaris works against allergic rhinitis is unknown. The nasal spray is marketed by Altana Pharma US. The company said the FDA also declared Omnaris approvable, though not yet approved, for children ages two to 11 years old.
The FDA said that in four randomized placebo controlled trials, lasting from two weeks to a year. patients treated with Omnaris had an 8% to 10% greater reduction in runny nose, nasal itching, sneezing, and nasal congestion than did those given placebo. The difference between Omnaris nasal spray and placebo was significant, said the FDA.
The most common side effects in clinical studies were headache, nosebleeds, and inflammation of the nose and throat linings, said the FDA.
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