Elite Pharmaceuticals Inc (ELTP)

[The ELTP King]

Lodrane update on ECR Pharma website:

Lodrane® 24 – Lodrane® 24D Update

On March 3, 2011 the FDA published a notice that some 500 long marketed and widely used cough, cold, and allergy products would have to cease distribution after August 31, 2011. Though many of these products had been available for more than 40 years and their ingredients recognized by the FDA as safe and effective, many had not been the subject of the current formal approval process. The extended release Lodrane® products (Lodrane® 24, Lodrane® 24 D, and Lodrane® 12D) were affected by this notice.

While ECR began additional work on the Lodrane® extended release products in 2010, the above notice did not provide time to complete the necessary work, submit this to the FDA, and secure the approvals in order to continue the marketing these products. ECR continues to proceed with the work to formalize approvals but at this time we cannot project when such may occur. We regret that this circumstance has left many patients without the therapeutic alternatives previously available.

In the interim, we have formulated an immediate release Lodrane® D Capsule which provides the same ingredients present in Lodrane® 24 D extended release capsule. Please see Lodrane® D Capsules in the Products section of this website for additional product and dosing information.