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

Xolair (omalizumab)

Patient Population Altered: July 7, 2016

• FDA Approves Genentech’s Xolair (omalizumab) for Allergic Asthma in Children

Differin (adapalene)

Labeling Revision Approved: July 8, 2016

• FDA Approves Differin Gel 0.1% for Over-the-Counter Use to Treat Acne

Repatha (evolocumab)

New Formulation Approved: July 8, 2016
Treatment for: High Cholesterol

• FDA Approves Repatha (evolocumab) Pushtronex - First And Only Single Monthly Injection for a PCSK9 Inhibitor

Repatha (evolocumab) FDA Approval History

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Patient Population Altered: July 11, 2016

• Pfizer Receives FDA Approval for Prevnar 13 in Adults Age 18 Through 49

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) 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

Prezista (darunavir)

Patient Population Altered: June 17, 2016

• U.S. FDA Approves Prezista (darunavir) for Use in Pregnant Women with HIV

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

Synjardy (empagliflozin and metformin) FDA Approval History

Belviq (lorcaserin)

New Formulation Approved: July 15, 2016

• Eisai Inc. and Arena Pharmaceuticals Announce FDA Approval of Belviq XR (lorcaserin HCl) Extended-Release Tablets

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

Relistor (methylnaltrexone bromide) 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

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 - formerly Lyxumia

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