FDA drug approvals-February 2015


FDA actions in brief, priority review, breakthrough designations, orphan drug designations

FDA actions in brief

Ceftazidime-avibactam (Avycaz, Forest) antibacterial was approved to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.

Panobinostat (FarydakNovartis Pharmaceuticals) was approved for the treatment of patients with multiple myeloma.

VenaSeal closure system (Covidien LLC and Medtronic) was approved to permanently treat varicose veins of the legs.

Expanded indication for lenalidomide (Revlimid, Celgene) in combination with dexamethasone was approved to include patients newly diagnosed with multiple myeloma. 

A supplemental New Drug Application was approved for rufinamide (BanzelEisai) as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients from aged 1 to 4 years old.

Lenvatinib (LenvimaEisai) was approved for the treatment of progressive, differentiated thyroid cancer.

The approved use of ranibizumab (LucentisGenentech) was expanded to treat diabetic retinopathy in patients with diabetic macular edema.

TissuGlu Surgical Adhesive (Cohera Medical Inc.) was approved for internal use.

Palbociclib (IbrancePfizer) was approved to treat metastatic breast cancer 

Olopatadine hydrochloride (Pazeo, Novartis and Alcon) 0.7% ophthalmic solution was approved for the treatment of ocular itching associated with allergic conjunctivitis.

Breathrough therapy designation

MPDL3280A (Roche) cancer immunotherapy antibody for treating non-small cell lung cancer.

LentiGlobin BB305 (bluebird bio) for the treatment of transfusion-dependent patients with beta-thalassemia major.

Priority review

Sirolimus (Rapamune, Pfizer) for the treatment of lymphangioleiomyomatosis, a rare lung disease.

LCZ696 (Novartis) for the treatment of heart failure patients with a reduced ejection fraction (HFrEF).

Nivolumab (Opdivo, Bristol-Myers Squibb) for use in patients with previously treated, advanced, squamous non–small cell lung cancer (NSCLC).

Trabectedin (YondelisJanssen) for treatment of patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.

Cobimetinib (Genentech, part of the Roche Group, and Exelixis) when used with Zelboraf, to treat a serious form of skin cancer known as BRAF V600 mutation-positive melanoma. 

Fast-track designation

Cannabidiol (CBD) (Insys Therapeutics) formulation for the treatment of Dravet syndrome, a rare form of childhood epilepsy.

Intranasal naloxone (Lightlake Therapeutics and Adapt Pharma Limited), an opioid antagonist for opioid overdose reversal treatment.

Orphan drug designations

PBI-4050 (ProMetic Life Sciences) anti-fibrotic for the treatment of idiopathic pulmonary fibrosis.

Pelareorep (Reolysin, Oncolytics Biotech) for the treatment of pancreatic cancer.

Entrectinib (Ignyta) for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer.

Saposin C (Bexion Pharmaceuticals), the active ingredient in its proprietary drug BXQ-350 for the potential treatment of glioblastoma multiforme.


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