said Thursday it has received clearance to sell the blood-pressure drug Exforge in the U.S.
The company, which said Exforge will be available soon, had received
conditional approval from the Food and Drug Administration in December. Exforge combines the company's Diovan and the ingredient in
The FDA's conditional approval in December took into account Pfizer's claim that Norvasc retained marketing exclusivity in the U.S. until September. But Pfizer recently
lost a patent challenge on Norvasc, and the drug has been subject to generic competition since late March. Exforge was approved by the European Union in January.
In the U.S., Exforge isn't approved as a first-line treatment for blood pressure. It's recommended for patients whose blood pressure hasn't been controlled by two classes of drugs -- angiotensin receptor blockers, which includes Diovan, and calcium channel blockers, like Norvasc. Exforge also can be used in patients who have experienced side effects from either Norvasc or Diovan.
By late morning, Novartis was down 42 cents to $52.10.