Most Read Articles
Pearl Toh, 01 Apr 2020
Short-term treatment (6 weeks) with 10 mg prednisolone effectively reduces finger pain and improves function in patients who have painful hand osteoarthritis (OA) coupled with signs of inflammation, the HOPE* study has shown.
31 Mar 2020
When treating fibromyalgia patients with low-dose naltrexone, the 4.5-mg dose appears to be a good choice, according to a recent study.
Elaine Soliven, 21 Apr 2020
Adding liraglutide to first-line lifestyle therapy led to a significantly reduced BMI standard-deviation score (BMI SDS*) among obese adolescents who failed to respond to lifestyle therapy alone, according to a study presented at ENDO 2020.
Elvira Manzano, 04 Mar 2020
Some patients with colitis are more likely than others to develop cuffitis after proctocolectomy with ileal pouch-anal anastomosis (IPAA), according to a retrospective study presented at the annual Crohn’s & Colitis Congress.

Original New Drug Application Approvals by US FDA (01 - 15 September 2019)

17 Sep 2019
New drug application approved by US FDA as of 01 - 15 September 2019 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.

GVOKE
  • Active Ingredient(s): Glucagon
  • Strength: 0.5 mg; 1 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Xeris Pharma, Inc.
  • Approval Date: 10 September 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.
  • Approved Label10 September 2019 (PDF)

IBSRELA
  • Active Ingredient(s): Tenapanor
  • Strength: 50 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Ardelyx, Inc.
  • Approval Date: 12 September 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
  • Approved Label12 September 2019 (PDF)
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Editor's Recommendations
Most Read Articles
Pearl Toh, 01 Apr 2020
Short-term treatment (6 weeks) with 10 mg prednisolone effectively reduces finger pain and improves function in patients who have painful hand osteoarthritis (OA) coupled with signs of inflammation, the HOPE* study has shown.
31 Mar 2020
When treating fibromyalgia patients with low-dose naltrexone, the 4.5-mg dose appears to be a good choice, according to a recent study.
Elaine Soliven, 21 Apr 2020
Adding liraglutide to first-line lifestyle therapy led to a significantly reduced BMI standard-deviation score (BMI SDS*) among obese adolescents who failed to respond to lifestyle therapy alone, according to a study presented at ENDO 2020.
Elvira Manzano, 04 Mar 2020
Some patients with colitis are more likely than others to develop cuffitis after proctocolectomy with ileal pouch-anal anastomosis (IPAA), according to a retrospective study presented at the annual Crohn’s & Colitis Congress.