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Lialda FDA Approval History

FDA Approved: Yes (First approved January 16, 2007)
Brand name: Lialda
Generic name: mesalamine
Dosage form: Delayed Release Tablets
Company: Shire plc
Treatment for: Ulcerative Colitis

Lialda (mesalamine) is a locally acting 5-aminosalicylic acid (5-ASA) indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.

Development timeline for Lialda

Jul 18, 2011Approval Lialda (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis
Jan 16, 2007Approval FDA Approves Lialda (mesalamine), the First Oral Once-Daily Mesalamine for Patients With Active, Mild to Moderate Ulcerative Colitis
Jan 16, 2007Approval Lialda Shire plc - Treatment for Ulcerative Colitis
Sep  8, 2006Shire Provides Update on U.S. Marketing Application of Mesavance (mesalamine) With MMX Technology
Dec 22, 2005Shire Announces Filing of Mesavance (mesalamine) for Treatment of Ulcerative Colitis

Further information

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