aaiPharma receives FDA approval to market Azasan
WILMINGTON, N.C., Feb. 4, 2003 aaiPharma Inc., AAII) announced that the U.S. Food and Drug Administration (FDA) has approved the Company's abbreviated new drug application (ANDA) for Azasan (azathioprine) 75 mg and 100 mg tablets. Previously unavailable, these new 75 mg and 100 mg Azasan tablet strengths will provide physicians with more flexible dosage options and contribute to enhanced patient compliance.
"Azathioprine is a proven and useful immunosuppressant, but until now physicians and patients have had to manage the inconvenience of a single oral dosage form," said Frank A. Snyder, MD, of Wilmington Internal Medicine, Adjunct Professor of the Vascular Biology Working Group, and Associate Professor at University of North Carolina at Chapel Hill. "By providing more dosing options, Azasan should offer physicians greater accuracy and flexibility when prescribing higher doses of azathioprine, and will make it easier for patients to take the medication as prescribed."
A survey by IMS in November 2002 indicated that 66 percent of all uses of azathioprine are at 100 mg or more per day. The new Azasan dosage forms may reduce the number of tablets patients would need to take to achieve an effective dose, a convenience that may translate into better therapeutic compliance. aaiPharma plans to launch the new products on March 1, 2003.
Chronic immunosuppression with this purine antimetabolite increases risk of neoplasia in humans. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. The most commonly reported side effects are leukopenia and/or thrombocytopenia, secondary infections, neoplasia, nausea, vomiting, diarrhea, fever, myalgias, skin rashes, and hepatotoxicity. Azasan therapy should be given cautiously when used concomitantly with allopurinol, ACE inhibitors, and other agents affecting myelopoiesis. Azasan is contraindicated in pregnant and lactating women and patients who have shown hypersensitivity to this product.
Source: aaiPharma Inc. www.aaipharma.com
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