Lupin receives USFDA approval for chronic pain drug

NEW DELHI: Drug maker Lupin on Wednesday said it has received approval from the US health regulator to market Tramadol Hydrochloride Extended Release Tablets, used to treat chronic pain in adults, in the American market.

The company's subsidiary Lupin Pharmaceuticals Inc has received approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tramadol Hydrochloride Extended-Release Tablets in strengths of 100 mg, 200 mg and 300 mg, Lupin said in a statement.

"Lupin will begin shipping its Tramadol ER shortly," the company said.

According to IMS Health sales data, Tramadol HCl ER tablets had annual sales of nearly USD 132 million for the 12 months to June 2011.

Lupin's product is the generic equivalent to Ortho-McNeil's 'Ultram ER Tablets' and is indicated to manage severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time, the company added.

Shares of Lupin today closed at Rs 449.95 on the Bombay Stock Exchange, down 2.08 per cent from its previous close.