Lupin receives FDA approval for generic Ultram ER tablets

BALTIMORE — Lupin has received final approval from the Food and Drug Administration for its version of a drug designed to treat moderate to moderately severe chronic pain in adults who require around-the-clock treatment for an extended period of time.

Lupin said that it received final approval for its abbreviated new drug application for tramadol hydrochloride extended-release tablets in the 100-mg, 200-mg and 300-mg strengths. The drug is a generic version of Ultram ER tablets, which is marketed by Johnson & Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals.

Tramadol HCl ER tablets is a centrally acting synthetic analgesic in an extended-release formulation, Lupin said. Annual sales for the product totaled approximately $132 million for the 12 months ended in June, according to IMS Health data.