New Drug Approvals Archive - 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.

• Insys Therapeutics Announces FDA Approval of Syndros (dronabinol) Oral Solution
• Syndros (dronabinol) FDA Approval History

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.

• FDA Approves Xiidra (lifitegrast ophthalmic solution) for Dry Eye Disease
• Xiidra (lifitegrast) FDA Approval History

Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) Extended-Release Tablets

Date of Approval: July 22, 2016
Company: Abbvie, Inc.
Treatment for: Chronic 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.

• AbbVie Receives U.S. FDA Approval of Once-Daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C
• Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) FDA Approval History

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.

• Sanofi Receives FDA Approval of Adlyxin (lixisenatide) for Treatment of Adults With Type 2 Diabetes
• Adlyxin (lixisenatide) FDA Approval History

Qbrelis (lisinopril) Oral Solution

Date of Approval: July 29, 2016
Company: Silvergate Pharmaceuticals, Inc.
Treatment for: Hypertension, Congestive Heart Failure, Myocardial Infarction

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.

• FDA Approves Qbrelis (lisinopril) Oral Solution for Pediatric Patients 6 Years of Age and Older
• Qbrelis (lisinopril) FDA Approval History