DRL gets Para IV for Ondansetron Tablets
Dr Reddy’s Laboratories announced that the US Food and Drug Administration has granted final approval for the company’s ANDA for Ondansetron Hydrochloride Tablets, 4 mg, 8mg, 16 mg and 24 mg. As the first company to file an ANDA containing a paragraph IV certification for this product, Dr Reddy’s has been awarded a 180-day period of marketing exclusivity. The company will commence the shipment of this product shortly.
G V Prasad, Vice-Chairman and CEO of Dr Reddy’s commented, “We are obviously pleased with the final approval of our generic version of Zofran with 180-days of marketing exclusivity. With six product introductions to date in the current year, we are making good progress in building a sustainable base generics business with potential upsides in the US in the medium term. This reaffirms our commitment to developing one of the largest pipelines in the US generic industry.”
As the first company to file a Para IV, DRL got a 180-day marketing exclusivity
Dr Reddy’s Ondansetron Hydrochloride Tablets are the AB-rated generic equivalent of GSK’s Zofran Tablets, a product indicated for the prevention of nausea and vomiting associated with cancer treatment. The brand product has annual IMS sales (June 2006 MAT) of approximately $639 million. The approval follows an order by the United States Court Of Appeals for the DC Circuit denying Apotex’s request that the FDA not approve Dr Reddy’s generic Zofran products pending a determination of its motion for a preliminary injunction.
In yet another announcement, Perlecan Pharma announced that the Phase I clinical trials for Dr Reddy’s novel anti-diabetic drug candidate DRL-16536 have started. DRL-16536 is a novel agent that works through activating the biological pathways (AMPK) responsible for beneficial effects of exercise. Targeting exercise pathway using the drug has provided robust glucose lowering and lipid lowering effects in pre-clinical disease models, while it additionally has the potential for weight loss. Current treatment options for type 2 diabetes work through other mechanisms and may not provide the overall beneficial clinical effects needed in this population which encompasses glycemic control, lipid control and body weight loss.
The Phase I clinical trials, being conducted in the Netherlands, would test the safety and tolerability of DRL-16536 in healthy volunteers. Commenting on the development, Dr K Anji Reddy, Chairman, Perlecan Pharma and Founder-Chairman, Dr Reddy’s said, “DRL 16536 is the fourth asset from Perlecan and is the third ‘first-in-class’ compounds from Dr Reddy’s discovery research, to go into clinical development. With the experience gained in modulation of this target, we at Dr Reddy’s are confident of discovering drugs for prevention and treatment of metabolic syndrome.”