- Email: [email protected]
Procedure for Submitting Reviews
WHAT DOES FDASIA MEAN FOR YOU / Novack d
The FDA reported that the government would not appeal a decision that appears to limit the agency’s regulation of pharmaceutical companies’ off-label drug marketing. The officials said the FDA would not ask the U.S. Supreme Court to hear a case called U.S. v. Caronia (January 2013).
MISCELLANEOUS NEWS NOTES d Duchesnay received FDA approval for DiclegisÒ (doxyla-
d
d
mine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting. Note that this combination was marketed in the previous century as BendectinÒ (April 2013). The U.S. is changing from a “first to invent” to a “first to file” patent system (March 2013). Vertex announced the initiation of a phase 3 study of VX-809 (lumacaftor) in com-
d
bination with ivacaftor for cystic fibrosis patients with a selected mutation. This combination received “Breakthrough Therapy” designation from the FDA, one of the new aspects of the FDASIA law of 2012 (February 2013). NuPathe announced that the FDA has approved ZecuityÔ (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine (January 2013).
THE OCULAR SURFACE / JULY 2013, VOL. 11 NO. 3 / www.theocularsurface.com
209
The FDA reported that the government would not appeal a decision that appears to limit the agency’s regulation of pharmaceutical companies’ off-label drug marketing. The officials said the FDA would not ask the U.S. Supreme Court to hear a case called U.S. v. Caronia (January 2013).
MISCELLANEOUS NEWS NOTES d Duchesnay received FDA approval for DiclegisÒ (doxyla-
d
d
mine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting. Note that this combination was marketed in the previous century as BendectinÒ (April 2013). The U.S. is changing from a “first to invent” to a “first to file” patent system (March 2013). Vertex announced the initiation of a phase 3 study of VX-809 (lumacaftor) in com-
d
bination with ivacaftor for cystic fibrosis patients with a selected mutation. This combination received “Breakthrough Therapy” designation from the FDA, one of the new aspects of the FDASIA law of 2012 (February 2013). NuPathe announced that the FDA has approved ZecuityÔ (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine (January 2013).
THE OCULAR SURFACE / JULY 2013, VOL. 11 NO. 3 / www.theocularsurface.com
209