FDA's NDA And BLA Approvals: Xepi, Admelog, Ixifi
Original new drugs and biologics recently approved by US FDA.
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Biohaven restructures its migraine partnership with Bristol to reduce its downstream royalty commitments. Meanwhile, the pharma partners with GRYT Health's cancer app for patient/caregiver insights into cancer therapy.
US FDA approved a New Drug Application for Intersect ENT's Sinuva mometasone furoate-eluting sinus implant in December. The implant elutes the cortical steroid to treat recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery and is supported by data from 400 patients, including the results from the RESOLVE II trial that showed Sinuva dramatically reduced the proportion of patients who needed another endoscopic sinus surgery.
Short-acting insulin approved under 505(b)(2) pathway appears poised to receive three years of Hatch-Waxman exclusivity but would lose nine months of this protection under FDA's current interpretation of the 'transition provisions' for certain protein products that take effect in March 2020.