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New Drug Approvals Archive - February 2014

February 2014

Imbruvica (ibrutinib)

New Indication Approved: February 12, 2014
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma; Chronic Graft Versus Host Disease

Read more: Imbruvica (ibrutinib) FDA Approval History

Vimizim (elosufase alfa) Injection

Date of Approval: February 14, 2014
Company: BioMarin Pharmaceutical Inc.
Treatment for: Mucopolysaccharidosis Type IVA

Vimizim (elosufase alfa) is an enzyme replacement therapy for patients with Mucopolysaccharidosis Type IVA (Morquio A syndrome).

Read more: Vimizim (elosufase alfa) FDA Approval History

Northera (droxidopa) Capsules

Date of Approval: February 18, 2014
Company: Chelsea Therapeutics International, Ltd.
Treatment for: Neurogenic Orthostatic Hypotension

Northera (droxidopa) is an orally active synthetic precursor of norepinephrine indicated for the treatment of neurogenic orthostatic hypotension.

Read more: Northera (droxidopa) FDA Approval History

Myalept (metreleptin) Injection

Date of Approval: February 24, 2014
Company: Amylin Pharmaceuticals, Inc.
Treatment for: Lipodystrophy

Myalept (metreleptin) is a leptin analog indicated to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

Read more: Myalept (metreleptin) FDA Approval History

Tivorbex (indomethacin) Capsules

Date of Approval: February 24, 2014
Company: Iroko Pharmaceuticals, LLC
Treatment for: Pain

Tivorbex (indomethacin) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain.

Read more: Tivorbex (indomethacin) FDA Approval History

Monovisc (sodium hyaluronate) Injection

Date of Approval: February 24, 2014
Company: Anika Therapeutics, Inc.
Treatment for: Osteoarthritis

Monovisc (sodium hyaluronate) is a viscoelastic supplement indicated for the treatment of pain associated with osteoarthritis of the knee.

Read more: Monovisc (sodium hyaluronate) FDA Approval History

New Drug Approvals Archive