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.
Read more: Syndros (dronabinol) FDA Approval History
Patient Population Altered: July 7, 2016
Labeling Revision Approved: July 8, 2016
New Formulation Approved: July 8, 2016
Treatment for: High Cholesterol; Prevention of Heart Attack and Stroke
- FDA Approves Repatha (evolocumab) Pushtronex - First And Only Single Monthly Injection for a PCSK9 Inhibitor
Read more: Repatha (evolocumab) FDA Approval History
Prevnar 13 (pneumococcal 13-valent conjugate vaccine)
Patient Population Altered: July 11, 2016
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.
Read more: Xiidra (lifitegrast) FDA Approval History
Patient Population Altered: June 17, 2016
Read more: Prezista (darunavir) FDA Approval History
Synjardy (empagliflozin and metformin)
Patient Population Altered: July 8, 2016
- FDA Expands Indication For Type 2 Diabetes Treatment Synjardy (Empagliflozin/Metformin Hydrochloride) To Include Treatment-Naïve Adults
New Formulation Approved: July 15, 2016
- Eisai Inc. and Arena Pharmaceuticals Announce FDA Approval of Belviq XR (lorcaserin HCl) Extended-Release Tablets
Read more: Belviq (lorcaserin) FDA Approval History
Relistor (methylnaltrexone bromide)
New Dosage Form Approved: July 19, 2016
- Valeant and Progenics Announce FDA Approves Relistor Tablets for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-Cancer Pain
Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) Extended-Release Tablets
Date of Approval: July 22, 2016
Company: Abbvie, Inc.
Treatment for: Chronic Hepatitis C
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
Adlyxin (lixisenatide) Injection - formerly Lyxumia
Date of Approval: July 27, 2016
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.
Read more: 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.
Read more: Qbrelis (lisinopril) FDA Approval History