US FDA approves Glenmark's corticosteroid
10 Aug 2010
Glenmark's US subsidiary has received US FDA approval for mometasone furoate topical solution USP, 0.1 per cent strength.
Glenmark says it plans to immediately start marketing and distributing the product in the US market.
"Mometasone furoate is a medium potency corticosteroid used for relief in inflammatory and pruritic manifestations corticosteroid- responsive dermatoses," the company said in a regulatory filing.
Like other topical corticosteroids, mometasone furoate has anti-inflammatory, anti-pruritic and vasoconstrictive properties.
The total market sales for the company's mometasone furoate product line is estimated approximately $25 million for the 12 month period ending June 2010 as reported by IMS Health.
This approval compliments Glenmark's portfolio of semi-solid dosage products and enhances its established line of mometasone furoate, which includes cream and ointment preparations.
Yesterday, Glenmark settled its patent dispute over generic Eszopiclone tablets with Sepracor Inc and signed a license agreement with them.(See: Glenmark enters into a settlement and license agreement with Sepracor Inc)