The US Food and Drug Administration (FDA) has granted Sun Pharmaceutical Industries' subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Ultram ER, Tramadol hydrochloride extended release tablets.
Tramadol HCL ER tablets are indicated for management of moderate to moderately severe chronic pain in adults who need around-the-clock treatment of their pain for an extended period of time.
These generic Tramadol hydrochloride extended release tablets, 100 mg, 200 mg and 300 mg. are therapeutically equivalent to Ultram ER tablets of Valeant. These tramadol HCL ER tablets have annual sales of approximately USD 125 million in US.