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New Drug Approvals Archive

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February 2014

February 12

Imbruvica (ibrutinib)

New Indication Approved: February 12, 2014
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia

Imbruvica (ibrutinib) FDA Approval History

February 14

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).

Vimizim (elosufase alfa) FDA Approval History

February 18

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.

Northera (droxidopa) FDA Approval History

February 24

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.

Myalept (metreleptin) FDA Approval History

February 24

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.

Tivorbex (indomethacin) FDA Approval History

February 24

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.

Monovisc (sodium hyaluronate) FDA Approval History

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