FDA approves generic lamotrigine ODT

The FDA has granted approval to Amring Pharmaceuticals Inc. for its generic lamotrigine ODT, according to a press release.

The treatment is indicated for epilepsy adjunctive therapy in patients aged 2 years and older, epilepsy monotherapy in patients aged 16 years and older and maintenance of bipolar I disorder in patients treated for acute mood episodes with standard therapy.

The medication is available in 25 mg, 50 mg, 100 mg and 200 mg tablets in bottles of 30, according to the release. The company said it has begun commercialization activities.

"We are pleased to add lamotrigine orally disintegrating tablets [ODT] USP to our generics portfolio,” Daniel Carbery, president and CEO of Amring, said in the release. “These products bring long-term value to patients and customers in our target markets. We look forward to realizing the benefits of these and other product launches and future business development activities in 2022.”