New Drug Approvals Archive - 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.

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

• FDA Approves Lucentis (ranibizumab) to Treat Diabetic Retinopathy in People with Diabetic Macular Edema
• 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.

• 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

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.

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

Banzel (rufinamide)

Patient Population Altered: February 12, 2015

• Eisai Receives Approval for Antiepileptic Drug Banzel (rufinamide) As Adjunctive Treatment For Pediatric Patients
• Banzel (rufinamide) FDA Approval History

Revlimid (lenalidomide)

New Indication Approved: February 17, 2015

• FDA Expands Indication for Revlimid (lenalidomide) in Combination with Dexamethasone to Include Patients Newly Diagnosed with Multiple Myeloma
• Revlimid (lenalidomide) FDA Approval History

Farydak (panobinostat) Capsules

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.

• 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

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: Contraception

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

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

Ibrance (palbociclib)

Labeling Revision Approved: February 19, 2016

• Pfizer Receives Expanded FDA Approval For Ibrance (palbociclib) In HR+, HER2- Metastatic Breast Cancer
• Ibrance (palbociclib) FDA Approval History

Lenvima (lenvatinib)

New Indication Approved: May 13, 2016

• FDA Approves Lenvima (lenvatinib) for the Treatment of Patients with Advanced Renal Cell Carcinoma
• Lenvima (lenvatinib) FDA Approval History

Ibrance (palbociclib)

Labeling Revision Approved: March 31, 2017

• Ibrance (palbociclib) Receives FDA Regular Approval and Expanded Indication for First-Line HR+, HER2- Metastatic Breast Cancer
• Ibrance (palbociclib) FDA Approval History

Liletta (levonorgestrel)

New Indication Approved: August 3, 2017

• FDA Approves Medicines360's sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Four Years
• Liletta (levonorgestrel) FDA Approval History

Avycaz (avibactam and ceftazidime)

New Indication Approved: February 1, 2018

• FDA Approves Avycaz (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
• Avycaz (avibactam and ceftazidime) FDA Approval History

Toujeo SoloStar (insulin glargine [rDNA origin])

New Formulation Approved: March 26, 2018

• FDA Approves Toujeo (insulin glargine) Max SoloStar
• Toujeo SoloStar (insulin glargine [rDNA origin]) FDA Approval History