Contraceptive Patch from Actavis Plc Rejected by FDA
US FDA has rejected the New Drug Application for transdermal contraceptive patch for women by Actavis Plc. The US regulator has asked the company to provide more data to support the claims for the patch. Ireland-based generic drug market Actavis said that the company will closely work with FDA and address their concerns.
The subsidiary of Actavis Plc received complete response letter from FDA Tuesday asking for details regarding the size and formulation different between the clinical trial transdermal patch and the one the company wants to sell in the markets. The patch will continuously deliver norethindrone over a period of seven day dosage regimen. Actavis had submitted NDA for contraceptive patch on May 13 this year.
The pregnancy control drugs commonly use two female hormones, estrogen and progestin. The company has planned first of its kind, patch with single hormone progestin.
Actavis submitted NDA with data for progestin-only patch. The clinical trials were performed by the company for twelve months at different centers.
Meanwhile, the company has also filed for marketing of Merck’s contraceptive vaginal ring, under brand name NuvaRing. The company management is confident to resolve the issues with FDA.
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