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New Drug Approvals Archive - February 2017

February 2017

Xyzal (levocetirizine dihydrochloride)

New Dosage Form Approved: January 31, 2017

Read more: Xyzal (levocetirizine dihydrochloride) FDA Approval History

Parsabiv (etelcalcetide) Injection

Date of Approval: February 7, 2017
Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism

Parsabiv (etelcalcetide) is a calcium-sensing receptor agonist indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Read more: Parsabiv (etelcalcetide) FDA Approval History

Emflaza (deflazacort) Tablets and Oral Suspension

Date of Approval: February 9, 2017
Company: PTC Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy

Emflaza (deflazacort) is a glucocorticoid for the treatment of Duchenne Muscular Dystrophy.

Read more: Emflaza (deflazacort) FDA Approval History

Siliq (brodalumab) Injection

Date of Approval: February 15, 2017
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Plaque Psoriasis

Siliq (brodalumab) is a human anti-interleukin-17-receptor monoclonal antibody for the treatment of plaque psoriasis.

Read more: Siliq (brodalumab) FDA Approval History

Qtern (dapagliflozin and saxagliptin) Tablets

Date of Approval: February 27, 2017
Company: AstraZeneca
Treatment for: Diabetes Type 2

Qtern (dapagliflozin and saxagliptin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor fixed-dose combination for the treatment of adult patients with type 2 diabetes.

Read more: Qtern (dapagliflozin and saxagliptin) FDA Approval History

Xermelo (telotristat ethyl) Tablets

Date of Approval: February 28, 2017
Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Carcinoid Syndrome Diarrhea

Xermelo (telotristat ethyl) is an oral tryptophan hydroxylase inhibitor indicated for use in combination with somatostatin analog (SSA) therapy for the treatment of carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors.

Read more: Xermelo (telotristat ethyl) FDA Approval History

New Drug Approvals Archive