ANDA specification and DRL submitted an amendment to the FDA on April 26, 2012, revising its ANDA specification and to request approval for the generic products.
In another development, Dr. Reddy's Laboratories subsidiary in USA has initiated voluntary recalling of IBU (TM) Ibuprofen Tablets, USP, 800 mg, and 500 -count bottle from the market on labelling issue.
"Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017.
"The correct expiration date is 10/2016,¿ US FDA website said on the reasons for recall (class-II).
A DRL official said the financial implications of the recall would be negligible.
Dr. Reddy's Laboratories shares was quoting at Rs 2421 apiece, down 1.42 per cent on BSE at 1.45 pm.