Lamical ODT Available as a Generic for Epilepsy and Bipolar Disorder
The U.S. FDA approved Impax’s generic to GlaxoSmithKline’s Lamical ODT (lamotrigine orally disintegrating tablets), a product approved for treating epilepsy and bipolar disorder. Generics to Lamictal tablets became available in 2008; however, this is the first market introduction for the orally disintegrating tablets.
The generic lamotrigine orally disintegrating tablets are available as 25mg, 50mg, 100mg and 200mg tablets in blister packaging and have already begun to be distributed.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a 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.