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ANDA filings

This article was originally published in The Tan Sheet

Executive Summary

Extended-release acetaminophen (Tylenol Arthritis), ibuprofen with pseudoephedrine (Advil Cold & Sinus) and ibuprofen oral suspensions and oral drops (Children's Motrin) among recent ANDA filings, according to CDER's Web site. An ANDA also has been filed for acetaminophen/aspirin/caffeine; Bristol-Myers Squibb's exclusivity for Excedrin Migraine expires Jan. 14, 2001. In addition, ANDAs for famotidine, ranitidine, ketoprofen and smoking cessation products were filed. FDA announced in May it will update the listings on its Web site monthly, but will not post the date ANDAs were received or the name of the filing company (1"The Tan Sheet" May 22, p. 2)

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ANDA filings

FDA soon will begin posting announcements of ANDAs filed with paragraph IV certification on the Office of Generic Drugs Web site. The agency plans to list the innovator drug and dosage strength, but not the company or the date FDA received it, according to OGD Acting Director Gary Buehler. The postings may alter generic firms' filing strategies; the first ANDA for a drug product filed with a paragraph IV certification is eligible for 180-day exclusivity, and companies may choose to defer developing patent challenges for products if they are ineligible for exclusivity. ANDAs may not be posted on the Web for up to 45 days after they are listed because of FDA filing requirements

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