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Sandoz launches US authorised generic of Miacalcin nasal spray

This article was originally published in Scrip

Executive Summary

Sandoz (Novartis) has launched in the US calcitonin-salmon nasal spray, an authorised generic version of the branded product Miacalcin, which is marketed by Novartis. In November 2008, the US FDAgranted final approval to Apotex's ANDA for a calcitonin-salmon nasal spray, and as first filer, Apotex has been granted 180 days of exclusivity. In December 2008, the FDA granted tentative approval to MDRNA (formerly Nastech Pharmaceutical) for its ANDA for the product; full approval is expected to follow after the completion of Apotex's exclusivity period (June 2009). In a statement, MDRNA said that in December 2003, the FDA accepted for filing its 505(j) paragraph four ANDAs for the product, and in October 2004, it entered into an exclusive licence and supply agreement with Par Pharmaceutical for US distribution and marketing. MDRNA is responsible for obtaining regulatory approval and manufacturing. Recently, Apotex was prohibited from marketing a generic version of Unigene's nasal calcitonin product, Fortical (calcitonin salmon rDNA origin), prior to a court ruling (Scrip Online, December 9th, 2008).

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