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FDA drug approvals: January 2014


FDA approvals, complete response, fast-track designations, priority review, first-time generic approval

FDA actions in brief

First gel sealant (ReSure Sealant, Ocular Therapeutix) was approved for use in stopping fluid from leaking through the incision in a patient's cornea after cataract surgery with itnraocular lens placement in adults.

Dapaglifozin tablets (Farxiga, Bristol-Myers Squibb and AstraZeneca) was approved to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. 

Trametinib (Mekinist, GlaxoSmithKline) for use in combination with dabrafenib (Tafinlar, GlaxoSmithKline) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved test. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma.

Umeclidinium and vilaneterol inhalation powder (Anoro Ellipta, GlaxoSmithKline) was approved for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease.

Anti-Inhibitor Coagulant Complex (FEIBA, Baxter) was approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors.

Coagulation Factor XIII A-Subunit (Recombinant) (Tretten, Novo Nordisk) was approved for use in the routine prevention of bleeding in adults and children who have a are clotting disorder, known as congenital Factor XIII A-subunit deficiency.

Expanded indication for prothrombin Complex Concentrate [Human] (Kcentra, CSL Behring) was approved to include the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients needing an urgent surgery or other invasive procedure.

Sumatriptan injection (Sumavel DosePro, Zogenix) needle-free delivery system supplemental New Drug Application for a 4-mg dose was approved for the treatment of migraine suffers who require management of side effects.

Sofosbuvir (Sovaldi, Gilead Sciences) oral tablets were approved as part of a regimen for the treatment of chronic hepatitis C virus infection caused by viruses of genotypes 1,2,3, or 4.

Collagenase clostridium histolyticum (Xiaflex, Auxilium Pharmaceuticals) was approved for treatment of men with Peyronie’s disease, bothersome curvature of the penis.

Sucroferric oxyhydroxide (Velphoro, Galenica) was approved for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

Posaconazole (Noxafil, Merck) 100 mg delayed-release tablets for the prophylaxis of invasive Aspergillus and Candida infections in patients, aged 13 years and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy.

Polidocanol injectable foam (Varithena, BTG) was approved for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein system.


Complete response

Fixed-dose combination (FDC) of canagliflozin (Invokana, Janssen Research & Development) and immediate-release metformin to treat adults with type 2 diabetes. The complete response letter related to the NDA requested additional information to support the comparability of the twice-daily dosing regimen of canagliflozin-as part of the canagliflozin and metformin FDC-and the once-daily dosing of canagliflozin as a single agent. Janssen believes it can supply this information based on available clinical data from the comprehensive phase 3 clinical development program for canagliflozin.

Priority review

Eliglustat (Cerdelga, Genzyme, a Sanofi company), an investigational oral therapy, for adult patients with Gaucher disease type 1.

Ofatumumab (Arzerra, GlaxoSmithKline and Genmab) supplemental Biologics License Application for use in combination with an alkylator-based therapy, to be used for treatment of chronic lymphocytic leukemia patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.

Fast-track designation

RPX7009 (Carbavance, The Medicines Company) novel beta-lactamase inhibitor with a carbapenem was designated as a Qualified Infectious Disease Product for intravaneous treatment of hospitalized patients with seriousn infections.

Technetium 99m tilmanocept (Lymphoseek, Navidea Biopharmaceuticals) Injection for sentinel lymph node detection in patients with head and neck cancer.

VB-111 (VBL Therapeutics) for prolongation of survival in patients with recurrent glioblastoma multiforme.

Isavuconazole (Astellas Pharma) once-daily intravenous and oral broad-spectrum antifungal was designated a Qualified Infectious Disease Product (QDIP) for the treatment of invasive aspergillosis. In addition to the QDIP designation, isavuconazole also has received fast-track and orphan drug designation for the treatment of zygomycosis, a life-threatening invasive fungal infection caused by emerging molds and invasive aspergillosis.

Orphan drug designation

KX02 (Kinex Pharmaceuticals), a dual src/pre-tubulin inhibitor, for treatment of gliomas, the most common and aggressive form of brain cancer.

Erdosteine (Alitair Pharmaceuticals) for the treatment of bronchiectasis.

68Ga-DOTATATE (GalioMedix, RadioMedix) as a diagnostic agent for the management of patients with neuroendocrine tumors.

Thymosin beta 4 (RegeneRx Biopharmaceuticals) for the treatment of neurotrophic keratopathy.

First-time generic approval

Abacavir Sulfate, Lamivudine, and Zidovudine Tablets, 300 mg (base)/150 mg/300 mg (equiv to Trizivir tablets, 300 mg (base)/150 mg/300 mg




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