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FDA drug approvals-May


FDA drug approvals, breakthrough designations, fast-track designations, priority review

FDA actions in brief

Omega-3-carboxylic acids (Epanova, AstraZeneca) was approved as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).

Umeclidinium (Incruse Ellipta, GlaxoSmithKline) once-daily anticholinergic was approved for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 

Ceritinib (Zykadia, Novartis) was approved for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

cobas HPV test (Roche) was approved for women aged 25 years and older that can be used alone to help a healthcare professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can offer information about the patient’s risk for developing cervical cancer in the future. 

Siltuximab (Sylvant, Janssen Biotech) was approved to treat patients with multicentric Castleman’s disease, a rare disorder similar to lymphoma (cancer of the lymph nodes).

Ramucirumab (Cyramza, Eli Lilly) was approved to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.

Short Ragweed Pollen Allergen Extract (Ragwitek, Merck) the first sublingual allergen extract to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), was approved in adults aged 18 years through 65 years.

Timothy Grass Pollen Allergen Extract (Grastek, Merck) tablet was approved for sublingual use.

Naloxone hydrochloride injection (Evzio, Kaléo, formerly Intelliject) was approved for emergency treatment when opioid overdose is known or suspected because of respiratory and/or central nervous system depression.

Dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim Pharmaceuticals) was approved for treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

A new indication for ofatumumab (Arzerra, GlaxoSmithKline and Genmab), a CD20-directed cytolytic monoclonal antibody, was approved in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

First sublingual allergen extract (Oralair, Stallergenes) for the treatment of allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people aged 10 through 65 years.

An expansion of the indication for ecallantide (Kalbitor, Dyax) was approved for the treatment of acute hereditary angioedema attacks, to include patients aged 12 years and older.

A new reconstitution system for Antihemophilic Factor [Recombinant] (Advate, Baxter) was approved. Advate and the diluent come pre-packaged in the new Baxject III reconstitution system.


Breakthrough designations

Meningococcal Group B Vaccine [rDNA, component, adsorbed]) (Bexsero, Novartis) to help protect against invasive meningococcal disease caused by serogroup B. 

Bivalent rLP2086 (Pfizer) for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in people aged 10 to 25 years. 

Priority review

Olaparib (AstraZeneca) for treatment of ovarian cancer.

Enzalutamide (Xtandi, Astellas and Medivation) capsules for treatment of chemotherapy-naive advanced prostate cancer,

Ledipasvir/Sofosbuvir (Gilead) fixed-dose combination tablet for treatment of chronic hepatitis C genotype 1 infection.

Eltrombopag (Promacta/Revolade, GlaxoSmithKline) for treatment of cytopenias in patients with severe aplastic anemia who have had insufficient response to immunosuppressive therapy.

Fast-track designations

Custirsen (OncoGenex) when administered in combination with cabazitaxel/prednisone as second-line chemotherapy to improve the survival outomes for prostate cancer patients.

Sativex (GW Pharmaceuticals) for the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.

Eravacycline (Tetraphase Pharmaceuticals) intravenous and oral formulations for treatment of complicated intra-abdominal infections.


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