First generic Nasonex available

April 1, 2016

FDA recently approved the first generic version of Nasonex nasal spray (mometasone furoate monohydrate, Apotex Corp).

FDA recently approved the first generic version of Nasonex nasal spray (mometasone furoate monohydrate, Apotex Corp).

Mometasone furoate is a nasal corticosteroid that acts to depress the formation, release and activity of inflammatory mediators that cause nasal congestion.

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Apotex stands to make a healthy profit from its generic Nasonex, since the brand drug made by Merck netted approximately $955.5 million in sales in the 12 months ending January, 2016. The wholesale acquisition cost of Nasonex nasal spray is $284.72.

"We are very pleased to make a more affordable version of this important allergy medicine available to the US public,” said Apotex CEO and president Dr Jeremy B. Desai. “Apotex is dedicated to bringing high quality versions of complex generic products to market, and we are delighted that these efforts will generate substantial savings for the US health care system,"

The nasal spray is approved for the treatment of nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older and for the prevention of nasal symptoms of seasonal allergic rhinitis in people 12 years of age and older. It is also indicated for the treatment of nasal polyps in patients 18 years of age and older.

Related: HSCA to FDA: Address backlog of generic drug applications

Nasonex must be dispensed with the label for patients to provide important information about the medication’s use and risks.

Patients should talk to their doctor or pharmacist if they have had a recent nasal sores, nasal surgery, or nasal injury; have eye or vision problems, have tuberculosis or any untreated fungal, bacterial, viral infections, or eye infections caused by herpes; or have been near someone who has chickenpox or measles. 

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