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DRL gets Para IV for Ondansetron Tablets
Hyderabad
 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."
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As the first company to file a
Para IV, DRL got a 180-day marketing exclusivity
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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."
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