aaiPharma receives approval and shared market exclusivity for Calcitriol Injection
WILMINGTON, N.C., Feb. 20, 2003 -- aaiPharma announced that the FDA has granted marketing approval for Calcitriol Injection, a liquid, injectable vitamin D product.
With this approval, the FDA has also granted shared market exclusivity to aaiPharma, and the company expects to launch its Calcitriol Injection vial within the next 45 days.
"This is another example of aaiPharma delivering on its strategy to acquire, improve and market well-known medicines," said Dr. Philip Tabbiner, President and Chief Executive Officer of aaiPharma. "The convenience of a vial is an important innovation in vitamin D injectable nutrition, and we expect that this unique attribute will be a benefit for health care professionals administering Calcitriol therapy."
The product is used primarily to treat chronic kidney dialysis patients with abnormally low levels of calcium in the circulating blood. Unlike other Calcitriol products, which are packaged as ampoules, aaiPharma's product is the only Calcitriol product with final approval for marketing in vial form, which may lead to greater ease of use in the hospital setting.
Calcitriol Injection is indicated in the management of hypocalcemia (abnormally low levels of calcium in the circulating blood) in patients undergoing chronic renal dialysis (artificial kidney function). It has also been shown to significantly reduce elevated parathyroid hormone (PTH) levels. Reduction of PTH levels has been shown to result in an improvement in defective renal bone formation.
Since Calcitriol is the most potent metabolite of vitamin D available, vitamin D and its derivatives should be withheld during treatment. Overdosage of any form of vitamin D may be dangerous.
Source: aaiPharma www.aaipharma.com
Posted: February 2003