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

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)