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Original New Drug Application Approvals by US FDA (1 - 15 July 2017)

28 Jul 2017
New drug applications approved by US FDA as of 1 - 15 July 2017 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.

OMEPRAZOLE
  • Active Ingredient(s): OMEPRAZOLE
  • Strength: 20MG
  • Dosage Form: Oral Disintegrating extended-release tablet
  • Company: Dexcel Pharma
  • Approval Date: July 5, 2017
  • Chemical Type: Type 8 - Partial Rx to OTC Switch
  • Indication(s): Indicated for the treatment of frequent heartburn (occurs 2 or more days a week)
  • Approved Label: 07/05/2017 (PDF)

ENDARI
  • Active Ingredient(s): L-GLUTAMINE
  • Strength: 5G
  • Dosage Form: Oral Powder
  • Company: Emmaus Medcl
  • Approval Date: July 7, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older
  • Approved Label: 07/07/2017 (PDF)

TREMFYA
  • Active Ingredient(s): GUSELKUMAB
  • Strength: 100MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Janssen Biotech
  • Approval Date: July 13, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
  • Approved Label: 07/13/2017 (PDF)

ZYPITAMAG
  • Active Ingredient(s): PITAVASTATIN
  • Strength: 1MG, 2MG, 4MG
  • Dosage Form: Oral Tablet
  • Company: Zydus Pharms USA Inc
  • Approval Date: July 14, 2017
  • Chemical Type: Type 2 - New Active Ingredient
  • Indication(s): Indicated for patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C)
  • Approved Label: 07/14/2017 (PDF)
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Most Read Articles
29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
Pearl Toh, Yesterday
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The CA125* test could be useful at detecting ovarian cancer and various other cancers in the primary care setting, particularly for women aged >50 years, according to a study presented at the recent NCRI** Cancer Conference held in Glasgow, Scotland, UK.