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Rediff.com  » Business » Caraco gets FDA nod for cardiac drug in US

Caraco gets FDA nod for cardiac drug in US

February 10, 2003 14:06 IST

Sun Pharmaceuticals' US-based associate, Caraco Pharmaceutical Laboratories, has received the approval from the US Food and Drug Administration to manufacture and market yet another generic drug, this time for the treatment of mild to moderate cardiac failure, in the US.

The drug, Digoxin, is the generic form of Glaxo Wellcome's Lanoxin, the company said. The current market for drugs used in the treatment of mild to moderate cardiac failure in the US is around $155 million. Caraco, in which Sun Pharmaceuticals has a 49 per cent stake, is the third company to launch the generic form of Lanoxin in the US.

Caraco will produce Digoxin in two strengths, 0.125 mg and 0.25 mg. Its sales targets for the product, however, could not be ascertained.

In a press statement on Sunday, Caraco's chief executive officer Narendra Borkar said the company has three more drugs that are currently pending the US FDA approval, and he expects approvals coming by year end. He added that the company also plans to file four new generic-drug applications with the FDA this year.

Digoxin is the tenth generic drug that the company has launched over the past six quarters.

These include the generic forms of Novartis' Clozaril (Clozapine), Hoffman LaRoche's Ticlid (ticlopidine hydrochloride), Sanofi Synthelabo's Demerol (meperidine hydrochloride), Bristol Myers Squibb's Glucophage (metformin hydrochloride), GD Searle's Daypro (oxaprozin), Novartis' Tegretol (carbamazepine, in the chewable form), Roche's Klonopin (clonazepam), Pharmacia's Ansaid (flurbiprofen) and RW Johnson Pharma Research Institute's Ultram (tramadol hydrochloride).

The Detroit-based Caraco had last year signed a five-year R&D agreement with Sun Pharma, whereby it will manufacture and market upto 25 generic drugs developed by Sun Pharma. The company develops, markets and distributes generic and private label drugs through its own distribution network in the US.

BS Corporate Bureau in Mumbai