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December 12, 2012
FDA accepts application for Takeda, Lundbeck antidepressant

The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

DEERFIELD, Ill. — The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

The FDA will review the companies' application for vortioxetine for the treatment of major depressive disorder in adults. The agency expects to finish reviewing the application by Oct. 2, 2013.

October 2, 2012
Takeda, Lundbeck seek FDA nod for depression drug

Drug makers Takeda Pharmaceutical and H. Lundbeck have applied with the Food and Drug Administration for a new drug to treat depression in adults.

OSAKA, Japan — Drug makers Takeda Pharmaceutical and H. Lundbeck have applied with the Food and Drug Administration for a new drug to treat depression in adults.

Japan-based Takeda and Denmark-based Lundbeck announced the submission of a new drug application for Lu AA21004 (vortioxetine) for major depressive disorder.

September 27, 2012
Dr. Reddy's launches generic asthma, allergy, bronchospasm drug

Dr. Reddy's Labs has launched a generic drug for treating asthma and allergies, and preventing bronchospasm during exercise, the company said.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug for treating asthma and allergies, and preventing bronchospasm during exercise, the company said.

The Indian company announced the launch of montelukast sodium oral granules in the 4-mg strength in unit-dose cartons of 30 packets.

The drug is a version of Merck's Singulair oral granules, which had sales of about $61 million during the 12-month period ended in July, according to IMS Health.