Ranbaxy arm gets US FDA clearance for lorazepam

Our Corporate Bureau

Mumbai, Aug 31: Ranbaxy Pharmaceuticals Inc (RPI), a wholly-owned subsidiary of Ranbaxy Laboratories Ltd has received FDA approval for lorazepam tablets USP, 0.5 mg, 1mg and 2 mg. Based on the bioequivalence studies, it has been deemed bioequivalent and therapeutically equivalent to Ativan tablets (which is a registered trademark of Wyeth Ayerst Laboratories.)

Lorazepam is indicated for the management of anxiety disorders or for short term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Sales in 2000 for lorazepam totalled $336.50 million, with sales of the tablet alone totalling $270.40 million (IMS-MAT December 2000). This has been a multisource product and the RPI approval represents the seventh ANDA approval granted for the tablet formulation of this product since patent expiration. However while all other ANDA holders are dependent on the two Active Pharmaceutical Ingredient (API) manufacturers for this product, Ranbaxy‘s approval is based on its own DMF.

The approved formulation is the result of research and development efforts which focussed on the API and the equivalent formulation, both of which were developed through the scientific capabilities residing with Ranbaxy Laboratories Ltd of New Delhi, India.
This represents the third ANDA approval awarded to RPI in 2001 that was granted by the FDA in a 9month timeframe.