Most Read Articles
Elvira Manzano, 4 days ago
Bisphosphonates have proven antifracture efficacy and remain to be the cornerstone of osteoporosis treatment. However, a drug holiday is of particular importance with bisphosphonates due to some signals with long-term use of the drug, including rare incidence of atypical femoral fracture (AFF) and osteonecrosis of the jaw (ONJ), says a leading endocrinologist at AFOS 2017.
Yesterday
Breast cancer patients have notably different microbiomes in the local breast tissue and urinary tract, a recent study reveals. Particularly, species in the Methylobacterium genus are reduced in the local breast tissue while the urinary tract is enriched in gram-positive bacteria.
Pearl Toh, 13 Oct 2017
Women with higher plasma tryptophan concentrations were less likely to have poor sleep quality during pregnancy, especially among those with anxiety symptoms, according to the GUSTO* study.
Tristan Manalac, Yesterday
Statin use, particularly in smokers, obese patients and nondiabetics, has a strong and dose-dependent association with decreasing risk of pancreatic ductal adenocarcinoma (PDAC), according to a new study.

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
Elvira Manzano, 4 days ago
Bisphosphonates have proven antifracture efficacy and remain to be the cornerstone of osteoporosis treatment. However, a drug holiday is of particular importance with bisphosphonates due to some signals with long-term use of the drug, including rare incidence of atypical femoral fracture (AFF) and osteonecrosis of the jaw (ONJ), says a leading endocrinologist at AFOS 2017.
Yesterday
Breast cancer patients have notably different microbiomes in the local breast tissue and urinary tract, a recent study reveals. Particularly, species in the Methylobacterium genus are reduced in the local breast tissue while the urinary tract is enriched in gram-positive bacteria.
Pearl Toh, 13 Oct 2017
Women with higher plasma tryptophan concentrations were less likely to have poor sleep quality during pregnancy, especially among those with anxiety symptoms, according to the GUSTO* study.
Tristan Manalac, Yesterday
Statin use, particularly in smokers, obese patients and nondiabetics, has a strong and dose-dependent association with decreasing risk of pancreatic ductal adenocarcinoma (PDAC), according to a new study.