After filing new drug application (NDA) under section (505 (b) (2) of the Federal Food, Drug and Cosmetic Act) for amlodipine maleate recently, Dr Reddy’s Laboratories has filed its second NDA with the US Food and Drugs Administration (FDA) under the same section. The product for which the second application has been filed is not known.

The filing under section 505 (b) (2) of the FFDC Act assumes significance since it allows a company to market its product with a possible de facto marketing exclusivity of up to three years based on the decision of the FDA, if the new drug is a slight modification of the original, or a new dosage form, or for a new indication.

Dr Reddy’s is the first Indian company to file an application under the section and one among the few in the world. The Company is now betting on amlodipine maleate for a strong foothold in the US and to make a windfall as in the case of fluoxetine. Its amlodipine maleate is slightly different from Pfizer’s amlodipine besylate through a change in salt composition. It is the generic version of Pfizer’s Norvasc and is indicated for the treatment of hypertension and angina with an annual brand sales of $2.5 billion in the US.

Participating in an analyst meet yesterday, Anji Reddy, the chairman of Dr Reddy’s, said clinical trials on insulin sesnsitiser compound balaglitazone (DRF-2593) were going well and hoped that it will enter into Phase III trials soon.

Novo Nordisk, after suspending Phase III clinical trials of ragagiltazar (DRF-2725) in July 2002, had said it would go ahead with the development of balaglitazone. This was outlicensed by Dr Reddy’s in March 1997 and has so far completed Phase II clinical trials.

On the anti-cancer compound DRF 1042, Reddy said that Phase II trials were initiated in Hyderabad, Chennai, Calcutta and Delhi, and would be completed in 12 to 18 months time.