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Takeda Files Actos/Metformin Combination Actoplus Met For Type 2 Diabetes

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Takeda’s antidiabetic Actos/metformin combination Actoplus Met could be on the market by fall 2005, assuming a standard NDA review timeline.

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Approvals In Brief

Tercica's Increlex measures up: Tercica will launch its extreme short stature therapy Increlex in January with a 30-member sales force following approval Aug. 30 with seven-year orphan drug exclusivity, the firm says. Increlex (mecasermin [rDNA origin]) is labeled for "long-term treatment of growth failure in children with severe primary IGF-1 deficiency (primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH." If and when competitor Insmed's SomatoKine (mecasermin rinfabate) is approved, FDA will decide a battle between the firms for orphan drug exclusivity in the extreme short stature market, Tercica predicts. SomatoKine, which has an Oct. 3 user fee date, is intended to treat growth hormone insensitivity syndrome, an indication encompassed by severe primary IGFD...

Takeda submits ramelteon

Takeda is seeking transient and chronic insomnia indications for its novel insomnia agent ramelteon in its Sept. 24 NDA submission. The MT-1/MT-2 melatonin receptor agonist is the first novel mechanism of action for a sleep agent "in 35 years," Takeda says. The firm noted that "in preclinical studies, ramelteon has shown no affinity for GABA or opiate receptors," which are common targets for sleep agents. The clinical program contained over 4,200 patients who received single daily doses for up to a year. Interim data from an ongoing year-long safety study is included in the NDA, as well as animal and human studies evaluating ramelteon's potential for drug dependence and abuse. Results will be presented at the U.S. Psychiatric & Mental Health Congress Nov. 18-21...

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

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