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Recipharm AB Supplies Clinical Trial Material for FDA Approved Phase IIb Study Sponsored by
2013-02-13 09:39:30| Appliances - Topix.net
February 12, 2013 -- Recipharm and PledPharma announce FDA approval of an IND application for Phase IIb clinical trial with PledOx, PLIANT, in the U.S. The material for PLIANT has been manufactured by Recipharm Pharmaceutical Development.
Tags: by
material
study
supplies
FDA vetoes Novo Nordisk insulin drug
2013-02-11 21:50:44| Biotech - Topix.net
The new long-acting insulin Tresiba drug is seen on a Novo Nordisk production line, in this 2012 handout picture provided by Novo Nordisk.
Novo Nordisk says FDA rejects insulin drugs
2013-02-11 00:57:46| Biotech - Topix.net
The Danish drugmaker says it received a "complete response letter" from the FDA regarding its applications for approval of Tresiba and Ryzodeg, or insulin degludec, on Friday.
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
FDA launches new nutrition facts labelling tool
2013-02-07 01:00:00| Packaging Gateway
The US Food and Drug Administration (FDA) has launched a new tool to help Americans achieve a heart-healthy lifestyle.
Tags: tool
facts
nutrition
launches
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