EC in Japan
This article was originally published in The Tan Sheet
Tokyo, Japan-based firm Sosei Group announces Nov. 17 the commencement of a Phase I clinical trial for the emergency contraceptive pill SOH-075 (NorLevo). The clinical trial is a randomized, double-blind, placebo-controlled study on a total of 33 Japanese adult female volunteers in three cohorts at a single study center. This will be the first emergency contraceptive pill introduced in Japan, the company says. The firm says it acquired the exclusive distribution rights to the product in Japan from Laboratoire HRA Pharma. In the U.S., Barr's emergency contraceptive pill Plan B became available for age-restricted sale behind pharmacy counters this month (1"The Tan Sheet" Nov. 13, 2006, p. 8)...
You may also be interested in...
The first product to be approved in a single package for both Rx and OTC sale - Barr Pharmaceuticals' emergency contraceptive Plan B - will be available behind pharmacy counters by mid-November, according to the firm
A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.