PharmaSages_Feb. FDA Approvals CHELSEA THERAPEUTICS INC : NORTHERA (DROXIDOPA) is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. BIOMARIN PHARM : VIMIZIM (ELOSULFASE ALFA) is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). AMYLIN PHARMS LLC : MYALEPT (METRELEPTIN) is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. New dosage form of TIVORBEX (INDOMETHACIN) from IROKO PHARMS LLC was approved for the treatment of mild to moderate acute pain in adults.

Pharma sages feb. fda approvals

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CHELSEA THERAPEUTICS INC: NORTHERA (DROXIDOPA) is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. BIOMARIN PHARM: VIMIZIM (ELOSULFASE ALFA) is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). AMYLIN PHARMS LLC: MYALEPT (METRELEPTIN) is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. New dosage form of TIVORBEX (INDOMETHACIN) from IROKO PHARMS LLC was approved for the treatment of mild to moderate acute pain in adults.

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PharmaSages_Feb. FDA ApprovalsCHELSEA THERAPEUTICS INC: NORTHERA (DROXIDOPA) is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. BIOMARIN PHARM: VIMIZIM (ELOSULFASE ALFA) is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). AMYLIN PHARMS LLC: MYALEPT (METRELEPTIN) is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

New dosage form of TIVORBEX (INDOMETHACIN) from IROKO PHARMS LLC was approved for the treatment of mild to moderate acute pain in adults.