Maxalt Paragraph IV Filing
This article was originally published in The Pink Sheet Daily
Executive Summary
The first ANDA with a Paragraph IV certification for Merck's migraine therapy Maxalt was filed Sept. 2, according to FDA's Nov. 3 updated list of Paragraph IV filings
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The first ANDA with a Paragraph IV certification for Merck's migraine therapy Maxalt was filed Sept. 2, according to FDA's Nov. 3 updated list of Paragraph IV filings. The "Orange Book" lists three patents that extend to February 2014 for Maxalt (rizatriptan). Third quarter U.S. sales for the triptan fell 24% to $57 mil. First-time ANDAs with Paragraph IV certifications also were filed for Celltech's cough treatment Tussionex on Sept. 10 and for 3M's MetroGel-Vaginal on Sept. 2, FDA's updated list says. |