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Dr Reddy's files second NDA in US

June 27, 2003 12:25 IST

Dr Reddy's Laboratories has filed its second new drug application with the US Food and Drugs Administration.

But the product for which the second application has been filed is not known.

Reddy's had filed its first NDA under the same section (505 (b) (2) of the Federal Food, Drug and Cosmetic Act for amlodipine maleate.

The drug is likely to be launched in August in the US upon successful completion of the ongoing litigation with Pfizer in an appellate court.

Participating in an analyst meet in Mumbai on Thursday, G V Prasad, CEO of Dr Reddy's, said the case would come up for hearing on July 9 and if the company wins it, it would co-market the drug in the US with a specialty pharma company.

The company also has to get final approval from the US FDA for the product.

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.

Dr Reddy's 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.

Briefing the analysts on discovery front, Anji Reddy, the chairman of Dr Reddy's, said clinical trials on insulin sensitiser compound balaglitazone (DRF-2593) were going well and hoped that "it will enter into phase-3 trials soon".

Danish pharma major Novo Nordisk, after suspending phase-3 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-2 clinical trials.

On the anti-cancer compound DRF 1042, Reddy said that Phase-2 trials were initiated in Hyderabad, Chennai, Kolkata and Delhi, and would be completed in 12 to 18 months time.

"We are also making preparations to submit INDA (investigational new drug application) in Canada soon", Reddy added.

G Singa Rao in Hyderabad