Most Read Articles
Elaine Soliven, 27 Nov 2019
High levels of trunk fat mass (FM) may be associated with an increased risk of cardiovascular disease (CVD)-related events such as coronary death, nonfatal myocardial infarction, or coronary heart disease in postmenopausal women with normal body mass index (BMI), according to a recent study presented at AHA 2019.
28 Nov 2019
Slideshow: Highlights from the American Heart Association (AHA) Scientific Sessions 2019
28 Oct 2019
The C-reactive protein (CRP)-to-albumin ratio (CAR) appears to be linked to the development of acute kidney injury in patients with ST elevation myocardial infarction (STEMI), a recent study has found.
28 Nov 2019
The addition of evolocumab to high-intensity statin therapy is both well tolerated and effective in significantly reducing low-density lipoprotein cholesterol (LDL-C) levels in patients hospitalized for acute coronary syndromes (ACS), allowing most of them to achieve current recommended target levels, a study has shown.

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

15 Jul 2019
New drug applications approved by US FDA as of 01 - 15 July 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.

XPOVIO
  • Active Ingredient(s): Selinexor
  • Strength: 20 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Karyopharm Therapeutics Inc.
  • Approval Date: 03 July 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
  • Approved Label03 July 2019 (PDF)

KATERZIA
  • Active Ingredient(s): Amlodipine benzoate
  • Strength: 1 mg/mL
  • Dosage Form(s) / Route(s): Suspension; oral
  • Company: Silvergate Pharms
  • Approval Date: 08 July 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): May be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
    • Hypertension: indicated for the treatment of hypertension in adults and children 6 years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily stroke and myocardial infarctions.
    • Coronary Artery Disease: Chronic Stable Angina; Vasospastic Angina (Prinzmetal's or Variant Angina); Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40%.
  • Approved Label08 July 2019 (PDF)
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Most Read Articles
Elaine Soliven, 27 Nov 2019
High levels of trunk fat mass (FM) may be associated with an increased risk of cardiovascular disease (CVD)-related events such as coronary death, nonfatal myocardial infarction, or coronary heart disease in postmenopausal women with normal body mass index (BMI), according to a recent study presented at AHA 2019.
28 Nov 2019
Slideshow: Highlights from the American Heart Association (AHA) Scientific Sessions 2019
28 Oct 2019
The C-reactive protein (CRP)-to-albumin ratio (CAR) appears to be linked to the development of acute kidney injury in patients with ST elevation myocardial infarction (STEMI), a recent study has found.
28 Nov 2019
The addition of evolocumab to high-intensity statin therapy is both well tolerated and effective in significantly reducing low-density lipoprotein cholesterol (LDL-C) levels in patients hospitalized for acute coronary syndromes (ACS), allowing most of them to achieve current recommended target levels, a study has shown.