FDA approves Lupin’s UltramR ER

Wednesday, August 31, 2011 01:04 PM

Lupin Pharmaceuticals has received final approval from the 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 ERshortly.

Tramadol HCl ER is a centrally acting synthetic analgesic in an extended release formulation.  It is the generic equivalent to Ortho-McNeil's UltramR 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.

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