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 April 2017)

15 Apr 2017
New drug applications approved by US FDA as of 1 - 15 April 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.

AUSTEDO

  • Active Ingredient(s): DEUTETRABENAZINE
  • Strength: 6MG; 9MG; 12MG
  • Dosage Form: Oral tablet
  • Company: Teva Pharms USA Inc
  • Approval Date: April 3, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of chorea associated with Huntington’s disease
  • Approved Label: 04/03/2017 (PDF)

INGREZZA
  • Active Ingredient(s): VALBENAZINE
  • Strength: 40MG
  • Dosage Form: Oral Capsule
  • Company: Neurocrine Biosciences Inc
  • Approval Date: April 11, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with tardive dyskinesia
  • Approved Label: 04/11/2017 (PDF)
Editor's Recommendations
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.