New Drug Approvals Archive - February 2015

Ibrance (palbociclib) Capsules and Tablets

Date of Approval: February 3, 2015
Company: Pfizer Inc.
Treatment for: Breast Cancer

Ibrance (palbociclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

• an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or
• fulvestrant in patients with disease progression following endocrine therapy.

• FDA Approves Ibrance (palbociclib) for Postmenopausal Women with Advanced Breast Cancer
• Ibrance (palbociclib) FDA Approval History

Dutrebis (lamivudine and raltegravir) Tablets

Date of Approval: February 6, 2015
Company: Merck
Treatment for: HIV Infection

Dutrebis (lamivudine and raltegravir) is a fixed-dose combination of a nucleoside analog reverse transcriptase inhibitor and an integrase strand transfer inhibitor for the treatment of HIV-1 infection.

Dutrebis is NOT commercially available in the U.S.

• FDA Approves Dutrebis (lamivudine and raltegravir) for HIV-1 Infection
• Dutrebis (lamivudine and raltegravir) FDA Approval History

Lenvima (lenvatinib) Capsules

Date of Approval: February 13, 2015
Company: Eisai Inc.
Treatment for: Thyroid Cancer, Renal Cell Carcinoma, Hepatocellular Carcinoma, Endometrial Cancer

Lenvima (lenvatinib) is a multiple receptor tyrosine kinase (RTK) inhibitor for the treatment of thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma.

• FDA Approves Lenvima (lenvatinib) for Differentiated Thyroid Cancer
• Lenvima (lenvatinib) FDA Approval History

Farydak (panobinostat) Capsules

Date of Approval: February 23, 2015
Company: Secura Bio, Inc.
Treatment for: Multiple Myeloma

Farydak (panobinostat) is a histone deacetylase inhibitor for use in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. 

• FDA Approves Farydak (panobinostat) for Multiple Myeloma
• Farydak (panobinostat) FDA Approval History

Avycaz (avibactam and ceftazidime) Injection

Date of Approval: February 25, 2015
Company: Actavis plc
Treatment for: Intraabdominal Infection, Urinary Tract Infection, Pneumonia

Avycaz (avibactam and ceftazidime) is a next generation, non-β lactam β-lactamase inhibitor and third-generation, antipseudomonal cephalosporin antibiotic combination for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia.

• FDA Approves Avycaz (ceftazidime and avibactam) for Complicated Abdominal and Urinary Tract Infections
• Avycaz (avibactam and ceftazidime) FDA Approval History

Toujeo SoloStar (insulin glargine [rDNA origin]) Injection - formerly Toujeo

Date of Approval: February 25, 2015
Company: Sanofi
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Toujeo SoloStar (insulin glargine [rDNA origin] is a once-daily long-acting basal insulin used to improve glycemic control in adults with type 1 and type 2 diabetes.

• Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo
• Toujeo SoloStar (insulin glargine [rDNA origin]) FDA Approval History

Liletta (levonorgestrel) Intrauterine Device

Date of Approval: February 26, 2015
Company: Medicines360 and Allergan plc
Treatment for: Birth Control

Liletta (levonorgestrel) is a hormonal intrauterine device (IUD) for use by women to prevent pregnancy for up to six years.

• FDA Approves Liletta (levonorgestrel-releasing intrauterine system) to Prevent Pregnancy for up to Three Years
• Liletta (levonorgestrel) FDA Approval History