Posted from: Friday, July 07, 2017 - 02:45 PM - Present

Generic Approved for Lialda

June 5, 2017 – The U.S. FDA has approved Zydus Cadila’s generic for Lialda® (mesalamine) 1.2g delayed-release tablets, manufactured by Shire. Mesalamine is taken orally to treat mild-to-moderate ulcerative colitis. The generic launch is projected for July or August, but pricing is currently unknown. IMS estimates that global sales for Lialda were $1.2 billion for the 12-month period ending on April 30, 2017. Zydus Cadila will have 180 days of generic exclusivity.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Thursday, November 23, 2017 - 10:41 AM.