Antares Pharma, Inc. (NYSE Amex: AIS) today announced the receipt from the U.S. Food and Drug Administration (FDA) of a waiver, on February 8, 2011, for the $1,500,000 New Drug Application (NDA) filing fee for Anturol® Gel for overactive bladder (OAB).
“We are pleased to have received the waiver for the NDA filing fee for the Anturol NDA. This waiver represents a significant accomplishment for the Company and helps maintain our strong cash position”
The waiver, requested by Antares in accordance with section 736(d)(1)(D) of the Federal Food, Drug and Cosmetic Act, is granted to a small business for the first human drug application that it submits to the FDA for review. To be considered for the waiver, a company must demonstrate it meets the size restrictions established by the Small Business Administration (SBA), which the SBA confirmed for Antares on January 14, 2011. The FDA will typically provide notice of acceptance of the NDA within 60 days of receipt of the waiver.
"We are pleased to have received the waiver for the NDA filing fee for the Anturol NDA. This waiver represents a significant accomplishment for the Company and helps maintain our strong cash position," said Paul K. Wotton Ph.D., President and Chief Executive Officer.
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