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New Drug Approvals Archive - February 2015

February 2015

Ibrance (palbociclib) Capsules

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 for the combination treatment of ER+, HER2- metastatic breast cancer.

Read more: Ibrance (palbociclib) FDA Approval History

Lucentis (ranibizumab)

New Indication Approved: February 6, 2015
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

Read more: Lucentis (ranibizumab) 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 will NOT be made commercially available in the U.S. at this time.

Read more: 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

Lenvima (lenvatinib) is an oral multiple receptor tyrosine kinase (RTK) inhibitor for the treatment of progressive radioiodine-refractory differentiated thyroid cancer and advanced renal cell carcinoma.

Read more: Lenvima (lenvatinib) FDA Approval History

Farydak (panobinostat) Capsules - formerly LBH589

Date of Approval: February 23, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: Multiple Myeloma

Farydak (panobinostat) is a histone deacetylase inhibitor for the combination treatment of multiple myeloma.

Read more: 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.

Read more: Avycaz (avibactam and ceftazidime) FDA Approval History

Toujeo SoloStar (insulin glargine [rDNA origin]) Injection

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.

Read more: Toujeo SoloStar (insulin glargine [rDNA origin]) FDA Approval History

Liletta (levonorgestrel) Intrauterine Device - formerly Levosert

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

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

Read more: Liletta (levonorgestrel) FDA Approval History

New Drug Approvals Archive