Law360, New York (July 09, 2004, 12:00 AM ET) -- Xcel Pharmaceuticals has filed a lawsuit against Par Pharmaceuticals subsidiary Kali Laboratories over Kali's filing of an abbreviated new drug application (ANDA) for a generic version of the rectal gel Diastat.
The lawsuit was filed last week in the U.S. District Court for the District of New Jersey.
Par said it believes that Kali is the first-to-file an ANDA with a paragraph IV certification for diazepam rectal gel and may be entitled to up to 180 days of marketing exclusivity for the product.
Under Hatch-Waxman rules,...
Xcel Sues Par Pharma Unit Over ANDA For Diastat Generic
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