Answers to Frequently Asked Questions Regarding the Mysoline® (primidone) 250 mg Change in Tablet Design
How is the “new” Mysoline 250 mg tablet different from the previous yellow-square tablet?
The new Mysoline 250 mg tablet is a round-white tablet that contains the same 250 mg of active ingredient (primidone) as the previous tablet version and is considered bioequivalent to the previous tablet version. The two tablets do differ slightly in their inactive ingredients. The lists of ingredients of both tablet versions are shown below:
“New” White-Round Tablet
Yellow-Square Tablet
Why did Valeant change the tablet design of Mysoline 250 mg tablets?
Valeant does not directly manufacture all of its pharmaceutical products – our previous manufacturing site was unable to continue to manufacture Mysoline 250 mg tablets so Valeant needed to qualify another manufacturing site to continue to produce the product. This new site (Watson) and version of the product has now been FDA approved, and the new Mysoline 250 mg tablet is considered bioequivalent to the previous version.
Will the previously available yellow-square Mysoline 250 mg tablet ever be available again?
Valeant is currently working to qualify an additional manufacturing site that will have the capability to produce Mysoline 250 mg tablets using the previous formulation and tablet design. We are working to validate this site and manufacturing process with FDA as quickly as possible, but are unable to provide a firm date as to when this will take place. If you would like to be notified if and when the yellow-square version of Mysoline 250mg tablets becomes available, please contact our Customer Service Team at 800-556-1937 to have your name and contact information added to our notification list.
When will this new Mysoline 250 mg tablet be available?
Valeant received FDA approval to market this new tablet design on June 13th, 2008 and we began shipping quantities of the product out to wholesalers on Monday, June 16th. We expect that Mysoline 250 mg tablets should be available through your local pharmacy just as quickly as your pharmacy can order it from their wholesaler or distributor.
How will my insurance coverage be affected?
This new tablet design has maintained the same NDC number as the previous Mysoline 250 mg tablet 100 count bottle, so your insurance coverage should not change from what it was previous to this change in tablet design.
To help patients without insurance coverage that may have difficulty affording their medication, Valeant has lowered the qualification criteria for our Mysoline Patient Assistance Program (PAP) to 300% of Federal Poverty Level (previously 200%). In order to access this Patient Assistance Program through Rx Hope, patients may visit
http://www.coping-with-epilepsy.com...rimidone-delay-brand-name-2917/www.rxhope.com and under the “Patients and Caregivers” section, click on “Search for Programs”. They can then select by medication or by company to view the PAP information and download an application. They can also inquire through our call center by calling 1-800-511-2120 between 8:00 am and 7:00 pm EST
Are there any other options if I do not wish to utilize the new Mysoline 250 mg tablets?
There are multiple manufacturers on the market for generic primidone 250mg tablets. Additionally, the current manufacturing changes affect the Mysoline 250 mg tablets only, and inventory of Mysoline 50 mg tablets from our previous manufacturing site is readily available, and unaffected by the changes outlined above. As is customary, when any changes occur with anticonvulsant therapy, we suggest that patients receive additional counseling from their physician.
For full Mysoline prescribing information, please click here.
