FDA drug approvals-August 2014


FDA actions in brief, complete response, fast-track designation, priority review, orphan drug designations, first-time generic approval

FDA Actions in Brief

A new indication for eltrombopag (Promacta, GlaxoSmithKline) was approved for once-daily use in patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy.

Abacavir 600 mg, dolutegravir 50 mg and lamivudine 300 mg (TriumeqViiV Healthcare) tablets were approved for the treatment of HIV-1 infection.

Diclofenac (ZorvolexIroko Pharmaceuticals) capsules were approved for the management of osteoarthritis pain.

Peginterferon beta-1a (Plegridy, Biogen Idec) for the treatment of adults with relapsing forms of multiple sclerosis. 

Fluticasone furoate inhalation powder (Arnuity Ellipta, GlaxoSmithKline) for maintenance treatment of asthma in patients aged 12 years and older. 

Eliglustat (Cerdelga, Genzyme) was approved to the long-term treatment of adult patients with the Type1 form of Gaucher disease, a rare genetic disorder.

The first zinc transporter 8 autoantibody (ZnT8Ab, KRONUS Market Development Associates) test has been allowed to be marketed to help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease.

Suvorexant (Belsomra, Merck) was approved for adults with insomnia who have difficulty falling asleep and/or staying asleep. Belsomra is a highly selective antagonist for orexin receptors.

Bevacizumab (AvastinGenentech, a member of the Roche Group) was approved to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

A fixed-dose therapy combining canagliflozin and metform hydrochloride (Invokamet, Janssen Pharmaceuticals) in a single tablet was approved to treat adults with type 2 diabetes. 

Oritavancin (Orbactiv, The Medicines Company) for injection was approved for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

Bortezomib (Velcade, Millennium: The Takeda Oncology Company) was approved for the retreatment of adult patients with multiple myeloma who had previously responded to Velcade therapy and relapsed at least 6 months following completion of prior Velcade treatment.

The approved use of alglucosidase alfa (Lumizyme, Genzyme) for treatment of patients with infantile-onset Pompe disease, was expanded to include patients of all ages, including those who are less than aged 8 years. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated. 

Empagliflozin (JardianceBoehringer Ingelheim) tablets were approved as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Olodaterol (Striverdi Respimat, Boehringer Ingelheim) inhalation spray was approved to treat patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema that are experiencing airflow obstruction.

Aflibercept (Eylea, Regeneron) Injection was approved for the treatment of diabetic macular edema.

Oxycodone hydrochloride and naloxone hydrochloride extended-release tablets (Targiniq ER, Purdue Pharma), an extended-release/long-acting (ER/LA) opioid analgesic was approved to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Idelalisib (Zydelig, Gilead Sciences) was approved to treat patients with 3 types of blood cancers. It has been approved to treat patients whose chronic lymphocytic leukemia (CLL) has relapsed. Used in combination with rituximab (Rituxan, Genentech, a member of the Roche Group), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (comorbidities). Zydelig also has been granted accelerated approval to treat relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL), another type of non-Hodgkin lymphoma. Zydelig is meant for patients who have received at least 2 prior systemic therapies.

Fluticasone propionate 50 µg spray (Flonase Allergy Relief, GlaxoSmithKline) was approved as an over-the-counter treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies.

The approved use of ibrutinib (Imbruvica, Pharmacyclics) in chronic lymphocytic leukemia (CLL) has been expanded to include patients with the chromosome 17p deletion.

Methotrexate (Rasuvo, Medac Pharma) injection was approved for rheumatoid arthritis, poly-articular-course juvenile idiopathic arthritis and psoriasis.

C1 Esterase Inhibitor [Recombinant] (Ruconest, Salix) was approved for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

Immune Globulin Intravenous [Human] (Octagam 10%, Octapharma) for the treatment of adults with chronic immune thrombocytopenic purpura, a platelet disorder that can result in easy or excessive bruising and bleeding.


Complete response

Sufentanil sublingual tablet system (Zalviso, AxcelRx Pharmaceuticals) to improve the management of moderate-to-severe acute pain in adult patients in the hospital setting by using a high therapeutic index opioid, through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. The complete response letter contains requests for additional information on the Zalviso System to ensure proper use of the device. The requests include provision of bench data demonstrating a reduction in the incidence of optical system errors which require premature drug cartridge change, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product. The company said it believes some of the requests have been addressed in amendments to the NDA that have been submitted prior to the receipt of the CRL but, as acknowledged by FDA, have not been reviewed. According to the company, there is no guarantee that the information previously provided to FDA will be adequate to address the issues in the CRL. Additional bench testing will be required and human factors testing may be required to address certain items in the CRL. There were no requests to conduct additional human clinical studies.   

Fast-track designations

PF-06425090 (Pfizer) investigational Clostridium difficile vaccine candidate for the prevention of C difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis.

SPN-810 (Supernus Pharmaceuticals) for the treatment of impulsive aggression in attention deficit hyperactivity disorder.

Pacritinib (CTI BioPharma) oral tyrosine kinase inhibitor with dual activity against JAK2 and FLT3 for the treatment of intermediate and high-risk myelofibrosis, including but not limited to patients with disease related thrombocytopenia, patients experiencing treatment emergent thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are sub-optimally managed on other JAK2 therapy.

Intransal naloxone spray (AntiOp and Reckitt Benckiser Pharmaceuticals) for the treatment of opioid overdose.

Priority review

Ivabradine (Amgen), an investigational oral drug that inhibits the If current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker, for the treatment of chronic heart failure.

Ruxolitinib (Jakifi, Incyte) for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

Bevacizumab (Avastin, Genentech, a member of the Roche Group) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.

Orphan drug designations

RG-012 (Regulus Therapeutics) for the treatment of rare kidney disease Alport syndrome.

rhNGF (Recombinant Human Nerve Growth Factor) (Dompé) for the treatment of neurotrophic keratitis.

Palovarotene (Clementia Pharmaceuticals) for the treatment of Fibrodysplasia Ossificans Progressiva.

First-time generic approval

Dexmedetomidine hydrochloride injection 100 µg (base)/mL, packaged in 200 µg (base)/2 mL single-dose vials (equiv to Precedex)

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