Biologics Approved In 2014
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA transferred review of most therapeutic biologics to the Center for Drug Evaluation & Research in 2003. The Center for Biologics Evaluation & Research continues to review other biologics, including vaccines, cellular products, antitoxins and immunoglobulins.
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Product & Sponsor |
Indication |
Date Approved (Application Number) |
|
Vimizim Elosulfase alfa BioMarin Pharmaceutical |
Enzyme replacement therapy addressing deficient activity of N-acetylgalactosamine-6-sulfatase (GALNS) for treatment of the autosomal recessive lysosomal storage disease Mucopolysaccharidosis Type IVA (MPS IVA, also called Morquio A Syndrome) |
2/14/2014 (125460) (P, V) |
|
Myalept Metreleptin Amylin Pharmaceuticals (Bristol-Myers Squibb)/AstraZeneca |
Leptin analog as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy |
2/24/2014 (125390) (P, V) |
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S: Standard Review P: Priority Review V: Orphan Drug H: Accelerated Approval B: Breakthrough Therapy Products approved by CBER are designated with an asterisk (*). |
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