Astellas Pharma Inc. and XenoPort, Inc. have announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS). The acceptance of filing of the NDA triggers a $5 million milestone payment from Astellas to XenoPort.

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Organon has announced the launch in India of its vaginal ring that contains the same hormones found in the oral pill, but is to be self-inserted only once-a-month for contraceptive action. The ring was approved by the US Food and Drug Administration in 2001. The Central Drugs Control Standards Organisation (CDSCO) in New Delhi approved the contraceptive ring for marketing in India in 2005.

The U.S. Food and Drug Administration has approved Duramed Pharmaceuticals’ LoSEASONIQUE(R) extended-cycle oral contraceptive. The product is the first lower-dose, extended-cycle oral contraceptive approved for the prevention of pregnancy. The LoSEASONIQUE(R) regimen requires women to take combination tablets for 84 consecutive days, followed by 0.01 mg ethinyl estradiol tablets for a week. The treatment reduces the periods of withdrawal bleeding to four from 13 per year.

A U.S. district court has ruled in favor of Barr Pharmaceuticals in a lawsuit challenging the patent listed by Bayer Schering Pharma in connection with Yasmin(R). The judge found the patent for the oral contraceptive as invalid. Yasmin provides an oral contraceptive regimen consisting of 21 active tablets (each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol) and 7 inert tablets.