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New Drug Approvals Archive - January 2014

See also: New Indications and Dosage Forms for January 2014

January 2014

Farxiga (dapagliflozin) Tablets

Date of Approval: January 8, 2014
Company: AstraZeneca
Treatment for: Diabetes Type 2, Heart Failure, Renal Failure

Farxiga (dapagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated for the treatment of type 2 diabetes mellitus, heart failure, and chronic kidney disease.

Aleve PM (diphenhydramine hydrochloride and naproxen sodium) Caplets

Date of Approval: January 16, 2014
Company: Bayer HealthCare LLC, Consumer Care
Treatment for: Pain, Insomnia

Aleve PM (diphenhydramine hydrochloride and naproxen sodium) is an over-the-counter antihistamine and nonsteroidal anti-inflammatory drug (NSAID) combination for the relief of occasional sleeplessness associated with minor aches and pains.

Hetlioz (tasimelteon) Capsules

Date of Approval: January 31, 2014
Company: Vanda Pharmaceuticals Inc.
Treatment for: Non-24-Hour Disorder; Smith-Magenis Syndrome Sleep Disturbance

Hetlioz (tasimelteon) is a melatonin receptor agonist for the treatment of Non-24-Hour Disorder in adults, and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.

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