New Drug Approvals Archive - July 2016
See also: New Indications and Dosage Forms for July 2016
July 2016
Syndros (dronabinol) Oral Solution
Date of Approval: July 1, 2016
Company: Insys Therapeutics, Inc.
Treatment for: Anorexia -- AIDS Patients; Nausea/Vomiting -- Chemotherapy Induced
Syndros (dronabinol) is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (THC) approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
Xiidra (lifitegrast) Ophthalmic Solution
Date of Approval: July 11, 2016
Company: Shire US Inc.
Treatment for: Dry Eye Disease
Xiidra (lifitegrast) is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease.
Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) Extended-Release Tablets
Date of Approval: July 22, 2016
Company: Abbvie, Inc.
Treatment for: Hepatitis C
Marketing Status: Discontinued
Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) is a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, NS5A inhibitor, NS3/4A protease inhibitor, and CYP3A inhibitor fixed-dose combination indicated for the once-daily treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1 infection.
Adlyxin (lixisenatide) Injection
Date of Approval: July 27, 2016
Company: Sanofi
Treatment for: Diabetes, Type 2
Adlyxin (lixisenatide) is a once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus.
Qbrelis (lisinopril) Oral Solution
Date of Approval: July 29, 2016
Company: Silvergate Pharmaceuticals, Inc.
Treatment for: High Blood Pressure, Heart Failure, Heart Attack
Qbrelis (lisinopril) is an oral solution formulation of the approved angiotensin converting enzyme (ACE) inhibitor lisinopril indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults.
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