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