FDA pushes back target date for review of Takeda drug in patients with ulcerative colitis
DEERFIELD, Ill. — The Food and Drug Administration has postponed the time it will decide whether or not to approve an experimental treatment under development by Takeda Pharmaceutical Co. for ulcerative colitis, the company said.
Takeda said the FDA had extended the Prescription Drug User Fee Act priority review action date for vedolizumab as a treatment for UC until May 20, 2014, essentially meaning the date has been pushed back. The FDA’s action date for the drug as a treatment for Crohn’s disease, June 18, 2014, remains unchanged. Takeda said the delay would give the agency enough time for a full review of the application.
"This short delay in the action date allows the FDA sufficient time to complete review of the vedolizumab file and provide action on the application," Takeda head of global regulatory affairs Tom Harris said. "We appreciate the work of the FDA and remain confident in the potential of vedolizumab as an additional, important treatment option for patients with the physicians who treat them for these serious conditions."
Actavis subsidiary seeks approval for generic version of NuvaRing
DUBLIN — Actavis said it was likely the first company to file with the Food and Drug Administration for approval of a generic version of a contraceptive device made by Merck, the generic drug maker said Tuesday.
Actavis said Warner Chilcott, now one of its subsidiaries, had filed with the FDA for approval of the ethinyl estradiol and etonogestrel vaginal ring in the 0.015-mg-per-day and 0.12-mg-per-day strengths. The device is a generic version of Merck’s NuvaRing.
In response to the filing, Merck and Dohme B.V. filed a patent-infringement lawsuit against Warner Chilcott Tuesday in the U.S. District Court for the District of Delaware in an effort to prevent the generic product from being marketed; the lawsuit puts an automatic stay of FDA approval on the generic for 30 months, unless the companies settle the matter sooner.
NuvaRing had sales of about $560 million during the 12-month period that ended in October, according to IMS Health.
Actavis contraceptive patch doesn’t win FDA approval
DUBLIN — The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.
Actavis said the FDA sent it a complete response letter for its progestin-only transdermal contraceptive patch. A complete response letter means that the agency has finished reviewing a drug-approval application, but questions remain that preclude final approval.
The FDA is requesting more data on the difference between the patch used in the clinical trial and the one Actavis intends to market, which is a different size and formulation, the company said.