received an approval letter from the Food and Drug Administration for an orally disintegrating version of its popular painkiller.
The FDA approved the 50-milligram dosage of orally disintegrating Tramadol, Biovail said Friday. The company is building on its painkiller franchise, and it received an approvable letter from the FDA for the extended-release version of the product in October.
In January, the FDA said it would approve the drug after labeling and packaging issues were resolved.
Biovail said it has patented oral disintegrating tablet technologies which let patients take medication without water and are more convenient to people with difficulty swallowing.
The company is in late-stage discussions with potential marketing partners. Tramadol is currently available under the brand name Ultram from a division of
Johnson & Johnson
, and it also can be found in several generic formulations.
Shares of Biovail rose 14 cents, or 1%, to $14.13 in Friday trading.