Most Read Articles
11 Dec 2017
Combining the DASH (Dietary Approaches to Stop Hypertension) diet with low sodium intake reduces systolic blood pressure (SBP) in individuals with pre- and stage 1 hypertension, with progressively higher reductions at greater levels of baseline SBP, a recent study has shown.
Tristan Manalac, 4 days ago
Major depressive disorder (MDD) appears to be more prevalent in females than in males, particularly in those who are divorced or widowed, a recent study from Singapore has found.
6 days ago
Tadalafil may not be effective for reducing the decline in ambulatory ability in boys with Duchenne muscular dystrophy (DMD), as shown in a recent study.
01 Dec 2017
At a symposium during the 25th Congress of the Obstetrical and Gynaecological Society of Malaysia in Kuala Lumpur, Professor Susan Davis discussed the unique implications of women living decades beyond menopause, and how healthcare professionals can best manage menopausal symptoms in the short and long term.

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
11 Dec 2017
Combining the DASH (Dietary Approaches to Stop Hypertension) diet with low sodium intake reduces systolic blood pressure (SBP) in individuals with pre- and stage 1 hypertension, with progressively higher reductions at greater levels of baseline SBP, a recent study has shown.
Tristan Manalac, 4 days ago
Major depressive disorder (MDD) appears to be more prevalent in females than in males, particularly in those who are divorced or widowed, a recent study from Singapore has found.
6 days ago
Tadalafil may not be effective for reducing the decline in ambulatory ability in boys with Duchenne muscular dystrophy (DMD), as shown in a recent study.
01 Dec 2017
At a symposium during the 25th Congress of the Obstetrical and Gynaecological Society of Malaysia in Kuala Lumpur, Professor Susan Davis discussed the unique implications of women living decades beyond menopause, and how healthcare professionals can best manage menopausal symptoms in the short and long term.