A proprietary biodegradable injectable gel with 5-FU (active agent), which uses a patented technology to provide sustained drug release at a tumour site—e.g., in non-melanoma skin cancers.
References in periodicals archive ?
Kanekal has led the nonclinical development and safety assessment of numerous drugs through the pre-clinical process all the way to NDA, including Treanda (Cephalon), Accusite, Omacetaxine and IntraDose.
Selling, general and administrative expenses rose 39% to $3,808,000 in the quarter from $2,732,000 in the year-earlier quarter, primarily due to higher personnel expenses, recruiting and relocation expenses, and product marketing expenses for AccuSite, which was introduced in the United Kingdom earlier this year.
Management suspended the AccuSite program after being notified that the Food and Drug Administration currently is not prepared to approve AccuSite as a treatment for genital warts.
Food and Drug Administration with respect to the company's New Drug Application (NDA) for AccuSite for treatment of genital warts.
AccuSite is a novel treatment for external genital warts that delivers the chemotherapeutic drug fluorouracil directly into wart tissues in a sustained-release formulation.
expenses for the launch of AccuSite in Europe, and higher personnel expenses.
We have filed an amendment to our AccuSite NDA which we believe fully addresses the concerns expressed by the FDA," said Craig R.
The Company's first product, AccuSite Injectable Gel, was introduced in the United Kingdom in January 1997 as a new treatment for genital warts and is under regulatory review for this indication elsewhere in Europe and in the United States.
NASDAQ/NMS: MATX) announced today that it has signed a distribution agreement with Dompe Farmaceutici of Milan for the sale of Matrix's AccuSite Injectable Gel product in Italy.
These were partially offset by lower expenses on clinical trials for AccuSite as well as the transfer of certain production expenses to inventory at year end.
The Archives of Dermatology article presents a Phase III study of AccuSite for the treatment of genital warts.
We expect to receive regulatory approval and to launch AccuSite in other key European countries later this year," McMullen added.