Ahmedabad-based drug major Cadila Healthcare (Zydus Cadila) has received the US drug regulator's nod to market Irbesartan tablets, an anti-hypertension drug, in the US market in strengths of 75 mg, 150 mg and 300 mg.
As per the NDC, the estimated sales of Irbesartan tablets in 2011 was around $ 489 million. "The group now has 72 approvals and has so far filed 150 ANDAs since the commencement of filing process in fiscal 2003-04", the company said in a statement here.
Zydus has previously received approvals to market two anti-hypertension drugs in the US market, Losartan Potassium tablets and Losartan Potassium plus Hydrochorothiazide tablets in October 2010.
The company has already launched both the products in the US market post approval from the health regulator. tablets is estimated at $944 million in 2010.
Earlier this year, Cadila Healthcare's US subsidiary Zydus Pharma USA Inc received the US Food and Drug Administration's (USFDA) nod to market oral tablets of Ultracet (Acetaminophen ;Tradamadol hydrochloride) in the US in September, while it received a tentative approval from the US FDA for Aripiprazole orally disintegrating tablets in August.
The drug is an anti-psychotic medication used in the treatment of schizophrenia.
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During August, the Ahmedabad based company also closed a definitive agreement regarding re-launch of Kinlytic (urokinase) in North American markets with Canada based biotechnology player Microbix Biosystems Inc. Urokinase is used in clearing pulmonary embolisms and intravenous catheter blockages, and has been administered to over four million patients since it was first approved in the US in 1978.
Zydus' consolidated revenue figures touched Rs 5263.31 crore during the 2011-12 financial year, up from Rs 4630.59 crore in the previous fiscal.