Sun Pharmaceutical Industries on Friday said it has received approval for the US health regulator to market generic version of Ultram ER tablets, a pain relieving drug, in the American market.
The company said US Food and Drug Administration has granted its subsidiary an approval for its abbreviated new drug application (ANDA) to market a generic version of Ultram ER, Tramadol hydrochloride extended release tablets, Sun Pharma said in a statement.
"These generic Tramadol hydrochloride extended release tablets, 100 mg, 200 mg and 300 mg are therapeutically equivalent to Ultram ER tablets of Valeant," it added.
According to the company, Tramadol HCL ER tablets have annual sales of nearly $125 million in US, it added.
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.
Shares of Sun Pharma on Friday closed at Rs 512.40 on the BSE, down 1.19% from its previous close.