Paladin Labs Inc. (TSX:PLB), a leading Canadian specialty pharmaceutical company, announced today that it has filed a new drug submission for SEASONIQUE® with the Therapeutic Products Directorate of Health Canada. SEASONIQUE® is the next generation of extended-cycle oral contraceptives for the prevention of pregnancy. Paladin signed a license and distribution agreement with Duramed Pharmaceuticals, Inc., a wholly owned subsidiary of Barr Pharmaceuticals, Inc. (NYSE:BRL), which granted Paladin the exclusive Canadian license to market SEASONIQUE®.
Takeda Pharmaceutical Company Limited (“Takeda”) today announced its submission of a New Drug Application of ramelteon for treatment of insomnia to the Ministry of Health, Labour and Welfare in Japan. Ramelteon works by selectively targeting two melatonin receptors in the brain, MT1 and MT2. These receptors are located in suprachiasmatic nucleus, a body’s ‘master clock’, which regulates circadian (24-hour) rhythms, including the sleep-wake cycle. By acting on these receptors, body’s sleep-wake cycle is regulated and physiological sleep is promoted.
PPD, Inc. today confirmed that Takeda Pharmaceutical Company Limited's new drug application (NDA) for alogliptin, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, has been accepted for filing by the U.S. Food and Drug Administration. PPD partnered with Takeda to develop the compound.
February 28, 2008- Alpharma Inc. (NYSE:ALO), a global specialty pharmaceutical company, today announced that a New Drug Application (NDA) has been submitted for EMBEDA, a pharmacological abuse-deterrent, extended-release morphine product candidate.
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