New Drug Approvals Archive - January 2014
Farxiga (dapagliflozin) Tablets
Date of Approval: January 8, 2014
Company: Bristol-Myers Squibb Company and AstraZeneca
Treatment for: Diabetes Type 2
Farxiga (dapagliflozin) is a selective sodium-glucose cotransporter-2 inhibitor for the treatment of adults with type 2 diabetes mellitus.
Read more: Farxiga (dapagliflozin) FDA Approval History
New Indication Approved: January 9, 2014
- GSK Gains Accelerated FDA Approval for Combination Use of Mekinist (trametinib) and Tafinlar (dabrafenib)
Read more: Mekinist (trametinib) FDA Approval History
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.
Copaxone (glatiramer acetate)
New Dosage Form Approved: January 28, 2014
Hetlioz (tasimelteon) Capsules
Date of Approval: January 31, 2014
Company: Vanda Pharmaceuticals Inc.
Treatment for: Non-24-Hour Disorder
Hetlioz (tasimelteon) is a melatonin receptor agonist for the treatment of Non-24-Hour Disorder in the totally blind.
Read more: Hetlioz (tasimelteon) FDA Approval History
Retin-A Micro (tretinoin)
New Dosage Form Approved: