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Kynamro Approval History

FDA Approved: Yes (Discontinued) (First approved January 29, 2013)
Brand name: Kynamro
Generic name: mipomersen
Dosage form: Injection
Company: Kastle Therapeutics
Treatment for: High Cholesterol, Familial Homozygous

Marketing Status: Discontinued

Kynamro (mipomersen) is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis indicated for the treatment of patients with homozygous familial hypercholesterolemia.

Development History and FDA Approval Process for Kynamro

DateArticle
Jan 30, 2013Approval FDA Approves New Orphan Drug Kynamro to Treat Inherited Cholesterol Disorder
Oct 19, 2012FDA Advisory Committee Recommends Kynamro for Homozygous Familial Hypercholesterolemia
May 29, 2012Genzyme and Isis Announce Filing of U.S. NDA for Kynamro (Mipomersen Sodium) in Homozygous Familial Hypercholesterolemia
Mar 29, 2012Genzyme and Isis Announce Submission of U.S. NDA for Kynamro (mipomersen sodium) in Homozygous Familial Hypercholesterolemia
Jan 11, 2011Isis Pharmaceuticals to Discuss Productive Regulatory Discussions Regarding the Mipomersen NDA Filing

Further information

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