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New Drug Approvals Archive - January 2014

January 2014

January 8

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.

Farxiga (dapagliflozin) FDA Approval History

January 9

Mekinist (trametinib)

New Indication Approved: January 9, 2014

Mekinist (trametinib) FDA Approval History

January 16

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.

Aleve PM (diphenhydramine hydrochloride and naproxen sodium) FDA Approval History

January 29

Copaxone (glatiramer acetate)

New Dosage Form Approved: January 28, 2014

January 31

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.

Hetlioz (tasimelteon) FDA Approval History

January 31

Retin-A Micro (tretinoin)

New Dosage Form Approved:

New Drug Approvals Archive