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Tag: fda approval
Perrigo Confirms FDA Approval For Testosterone Gel 1%
2013-02-07 04:10:50| Biotech - Topix.net
Perrigo Company announced that it has received U.S. Food and Drug Administration approval for its New Drug Application for testosterone gel 1%. Perrigo's NDA included a bioequivalence study that compared its product to AbbVie's AndroGel 1%. AndroGel 1% is indicated to treat adult males who have low or no testosterone.
Tags: approval
gel
confirms
fda
Genzyme And Isis Announce FDA Approval Of KYNAMRO (Mipomersen Sodium) Injection For The Treatment Of Homozygous Familial Hypercholesterolemia
2013-01-29 19:30:00| drugdiscoveryonline News Articles
Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for KYNAMRO (mipomersen sodium) injection
Tags: treatment
approval
injection
announce
J&J gets FDA approval for Sirturo, first drug for drug-resistant tuberculosis
2013-01-01 08:47:15| Food - Topix.net
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Tags: drug
approval
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tuberculosis