New Drug Approvals Archive - February 2015
See also: New Indications and Dosage Forms for February 2015
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.
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.
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.
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.
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.
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.
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.
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