FDA approves Lupin’s pain pill

 

Lupin Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for Tramadol hydrochloride extended release tablets in the US.

Tramadol ER is the generic version of Ortho-McNeil’s Ultrum ER tablets, indicated for the management of moderate to moderately severe chronic pain in adults who require 24/7 treatment of their pain for an extended period of time.

The company said that it will be “shipping its Tramadol ER shortly”.

Mumbai-based Lupin Limited is a global pharmaceutical company producing both generic and branded formulations and APIs. Its Lupin Pharmaceuticals headquarters is based in Baltimore, Maryland, USA.