DRL Gets USFDA Nod For AmVaz

Hyderabad, Nov 3: | Updated: Nov 4 2003, 05:30am hrs
Dr Reddys Laboratories (DRL) has announced that the US Food and Drug Administration (USFDA) has approved the companys NDA for AmVaz (Amlodipine Maleate). Commenting on the development, Mr GV Prasad, CEO of Dr Reddys Laboratories said that the approval from US FDA marks a milestone as the company is the first Indian pharmaceutical company to receive FDA approval for a NDA under Sec 505 (B) (2) of the Federal Food, Drug and Cosmetics Act.

This marks the setting of stage for the launch of first specialty branded product in the US markets, he said in a press release. We have not made a final decision for the launch date but we are making necessary preparations for the launch and also in the process of finalising a co-promotion partner for AmVaz in the US, Mr Prasad said through the release. During the current fiscal, the company expects to file 15-18 ANDAs, 15 DMFs and additional NDAs.

Besides the launch, the company has formulated development programmes on a number of differentiated compounds in major therapeutic categories and expects additional NDA filings during the current fiscal. Meanwhile, the company is also preparing to launch AmVaz in Europe upon expiry of the Supplementary Protection Certificate in March 2004. The US product pipeline comprises 27 ANDAs, 2 NDAs including Amlodipine Maleate and 44 DMFs, the release added.