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Pank Jit Sin, 19 Nov 2018
Primary care practitioners will now have access to an expert derived handbook as reference for the treatment of urticaria. 

Original New Drug Application Approvals by US FDA (1– 15 Feb 2016)

15 Feb 2016
New drug applications approved by US FDA as of 1 - 15 Feb 2016 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

PARICALCITOL
  • Active Ingredient(s): Paricalcitol
  • Strength: 2MCG/ML, 5MCG/ML, 10MCG/2ML
  • Dosage Form: Injectable, injection
  • Company: Accord Hlthcare
  • Approval Date: February 4, 2016
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(s): Indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5
  • Approved Label: Not available

SERNIVO
  • Active Ingredient(s): Betamethasone dipropionate
  • Strength: 0.05%
  • Dosage Form: Topical spray
  • Company: Promius Pharma LLC
  • Approval Date: February 5, 2016
  • Chemical Type: 3  New dosage form
  • Indication(s): Indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older
  • Approved Label: 02/05/2016 (PDF)

ROSUVASTATIN ZINC
  • Active Ingredient(s): Rosuvastatin zinc
  • Strength: 5MG, 10MG, 20MG, 40MG
  • Dosage Form: Oral tablet
  • Company:Watson Labs Inc
  • Approval Date: February 12, 2016
  • Chemical Type: 2  New active ingredient
  • Indication(s): Indicated for a) adult patients with hypertriglyceridemia as an adjunct to diet; b) adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet; c) adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB
  • Approved Label: Not available
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Most Read Articles
Pank Jit Sin, 19 Nov 2018
Primary care practitioners will now have access to an expert derived handbook as reference for the treatment of urticaria.