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Lialda Approval History

  • FDA approved: Yes (First approved January 16th, 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 History and FDA Approval Process 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

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