Lupin Receives Final Approval to Market Generic Ultram® ER from US FDA
Lupin Pharmaceuticals, Inc. (LPI) announced on 29th aug, 2011 that it has received final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride Extended-Release Tablets, 100, 200 and 300 mg strengths. Lupin will begin shipping its Tramadol ER shortly.
Tramadol HCl ER is a centrally acting synthetic analgesic in an extended release formulation. It is the generic equivalent to Ortho-McNeil’s Ultram®* ER Tablets and is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
Tramadol HCl ER tablets had annual sales of approximately $132 million for the twelve months ended June 2011 based on IMS Health sales data.
Source: Lupin Pharma
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