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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