FDA approves Lupin’s UltramR ER
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.