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Antares Otrexup Approved for Self Injection

[ Price : $8.95]

FDA approves an Antares Pharma NDA for Otrexup (methotrexate) injection, a subcutaneous methotrexate formulation for once weekly s...

Nepron Recalls 10 Albuterol Lots

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Nephron Pharmaceuticals recalls 10 lots of albuterol sulfate inhalation solution, 0.083%, in a 25-count packaging configuration.

CA Governor Brown Vetoes Biosimilar Bill

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Gov. Jerry Brown (D-CA) vetoes a bill that would have allowed biosimilar product substitution for products once FDA has made a det...

Positive Data in NPS Pharma Short Bowel Syndrome Trial

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NPS Pharmaceutical reports new data from a Phase 3 study of the long-term use of Gattex for injection in adults with Short Bowel S...

FDA Probes Increasing Blood Clot Reports with Iclusig

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FDA says it is investigating increasing reports of serious and life-threatening blood clots and severe narrowing of blood vessels ...

FDA Approves New Dosing for Medicures Aggrastat

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FDA approves a Medicure sNDA for a new dosing regimen for Aggrastat (tirofiban HCl).

FDA Clears Crospon 510(k) for EsoFLIP Dilation Catheter

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FDA clears a Crospon 510(k) for its EsoFLIP balloon dilation catheter for procedures in the esophagus and colon.

FDA Clears Ranbaxy U.S. Manufacturing Facility

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FDA tells Ranbaxy that its U.S. generic drug subsidiary, Ohm Laboratories, has resolved GMP issues cited in a 12/2012 inspection o...

FDA Accepts Xolair sBLA for Chronic Idiopathic Urticaria

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FDA accepts a Genentech supplemental BLA for subcutaneous use of Xolair (omalizumab) in people with chronic idiopathic urticaria.

FDA Approves Sanofis OTC Nasacort Allergy Spray

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FDA approves a Sanofi NDA for an over-the-counter version of its Nasacort Allergy 24-hour nasal spray.