FDA drug approvals-June 2014


FDA actions in brief, breakthrough therapy designations, fast-track designations, first-time generic approval

FDA actions in brief

Phenylephrine and ketorolac injection (Omidria, Omeros) 1%/0.3% was approved for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain. 

Palonosetron HCl (Aloxi, Eisai and Helsinn Group) injection was approved for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged 1 month to less than 17 years. This is the first approval of a product for acute chemotherapy-induced nausea and vomiting prevention in patients aged 1 month to 6 months.

FDA allowed marketing of the EUROIMMUN Anti- PLA2R IFA (EUROIMMUN US, Inc..) blood test that can help determine if a specific type of kidney disease, called membranous glomerulonephritis (MGN), is due to the body’s rejection of its own kidney tissue (autoimmune) or if it is due to another cause (such an infection). The test detects if a patient has an antibody (a protein molecule the body’s immune system produces) that is specific to pMGN.

Testosterone nasal gel (Natesto, formerly CompleoTRT, Trimel Pharmaceuticals) was approved for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

CardioMEMS HF System (CardioMEMS, Inc.), a permanently implantable device, that measures the pulmonary artery (PA) pressures and heart rates of patients with New York Heart Association (NYHA) Class III heart failure who have been hospitalized for heart failure in the previous year. With the device, patients who are at home or another location will be able to be monitored remotely by a healthcare professional.

Panitumumab (Vectibix, Amgen) for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with wild-type KRAS (exon 2) metastatic colorectal cancer. The therascreenKRAS RGQ PCR Kit from QIAGEN (therascreenKRAS test) was also approved as a companion diagnostic for Vectibix.

Beclomethasone diproprionate HFA (Qvar, Teva) with a dose counter was approved for the ongoing treatment of asthma as preventative therapy in patients aged 5 years and older.

Dalbavancin (Dalvance, Durata Therapeutics) was approved for injection for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

A new indication was approved for Kogenate FS antihemophilic factor VIII (recombinant) (Bayer) to include routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.  

Vorapaxar (Zonitivity, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.) was approved to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.

Vedolizumab (Entyvio, Takeda) injection was approved to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease.


Breakthrough therapy designations

Elotuzumab (Bristol-Myers Squibb and AbbVie), an investigational humanized monoclonal antibody, for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received 1 or more prior therapies.

Nivolumab (Bristol-Myers Squibb), a PD-1 immune checkpoint inhibitor for the treatment of Hodgkin lymphoma.

Fast-track designations

CVac clinical development program (Prima BioMed), which is intended to improve overall survival in patients with relapsed platinum-sensitive epithelial ovarian cancer who enter a second complete remission.

Obeticholic acid (Intercept) for the treatment of patients with primary biliary cirrhosis.

Doxorubicin Transdrug (Livatag, BioAlliance Pharma) for the treatment of hepatocellular carcinoma after treatment with sorafenib.

ANG1005 (Angiochem) a novel paclitaxel-peptide drug conjugate leveraging the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer, for the treatment of glioblastoma multiforme (GBM). ANG1005 was also granted orphan drug designation.

First-time generics

Celecoxib capsules in in 50-mg, 100-mg, 200-mg, and 400-mg strengths (equiv to Celebrex)


Azelastine hydrochloride nasal spray (equiv to Astepro)


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