EC soon available in Japan
23rd February 2011
HRA Pharma’s emergency contraceptive, NorLevo®, is expected to be launched on the Japanese market by ASKA Pharmaceutical in the first half of 2011.
The Japan Ministry of Health, Labour and Welfare (MHLW) granted approval for NorLevo® (levonorgestrel, 0.75mg) as a prescription-only emergency contraceptive indicated for use within 72 hours (three days) of unprotected intercourse or a known or suspected contraceptive failure. NorLevo® has thus become the first emergency contraceptive pill available in Japan.
Marketed in Europe since 1999 and currently approved in more than 50 countries, NorLevo’s approval in Japan is based on a complete development program including preclinical and clinical trials conducted locally by HRA Pharma’s partner Sosei.
“We are pleased to be able to offer Japanese women an important tool for the management of their reproductive health. The Japanese approval of NorLevo caps a 10-year development and registration program and represents a major milestone, as it is the first product to have been specifically approved for use as an oral emergency contraceptive in Japan,” said Erin Gainer, CEO of HRA Pharma. “This is also a major step for our company, as it is our first product to reach the Japanese marketplace. This accomplishment paves the way for the introduction of future HRA Pharma products into the world’s second largest pharmaceutical market.”
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