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FDA drug approvals-April 2015


FDA actions in brief, priority review, breakthrough therapy designation, fast-track designations, orphan drug designations, first-time generic approvals

FDA actions in brief

An expansion onabotulinumtoxinA (Botox, Actavis) label was approved to include the treatment of adults with upper limb spasticity. The expanded label now includes the addition of two thumb muscles: flexor pollicis longus, a muscle in the forearm that flexes the thumb; and adductor pollicis, a muscle in the hand that functions to adduct the thumb; increasing the maximum dose from 360 to 400 units for the treatment of upper limb spasticity.

Ivabradine (Corlanor, Amgen) was approved to reduce hospitalization from worsening heart failure.

Gastric Emptying Breath Test (Advanced Breath Diagnostics), a non-invasive test, was approved to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.

Hydrogel (SpaceOAR, Augmenix Inc.) was cleared for men undergoing prostate cancer (PCa) radiotherapy. SpaceOAR is injected before radiation therapy to create a temporary space between a patient’s prostate gland and rectum.


Fast-track designations

GZ/SAR402671 (Genzyme), an investigational oral substrate reduction therapy for the treatment of Fabry disease.

CRLX101 (Cerulean Pharma) nanoparticle-drug conjugate in combination with bevacizumab (Avastin, Genentech) for the treatment of metastatic renal cell carcinoma (mRCC) following progression through 2 or 3 prior lines of therapy.

lonafarnib (Eiger BioPharmaceuticals) in combination with ritonavir (Norvir, AbbVie) for treatment of hepatitis delta virus infection.

Interferon gamma-1b (Actimmune, Horizon Pharma) for the treatment of Friedreich's ataxia or FA, a degenerative neuro-muscular disorder.

Cabozantinib (Cometriq, Exelixis) for the treatment of patients with advanced renal cell carcinoma who have received 1 prior therapy.

PER977 (Perosphere), an investigational anticoagulant reversal agent.

DX-2930 (Dyax) for treatment of hereditary angioedema attacks.

MN-001 (tipelukast, MediciNova) for the treatment of patients with nonalcoholic steatohepatitis (NASH) with fibrosis.

Idebenone (Raxone/Catena, Santhera Pharmaceuticals) for treatment of Duchenne Muscular Dystrophy. 


Priority review

Ticagrelor (Brilinta, AstraZeneca) tablets for patients with a history of heart attack.

Idarucizumab (Boehringer Ingelheim) to reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa (dabigatran etexilate mesylate) in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event. 

Brentuximab vedotin (Adcetris) as a consolidation therapy following autologous stem cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression.

Lifitegrast (Shire) for drug eye disease in adults.  

Breakthrough therapy designation

Rucaparib (Clovis Oncology), an investigational agent ras monotherapy treatment of advanced ovarian cancer in patients who have received at least 2 lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations.

First-time generic

Glatiramer acetate injection, 20-mg/1-ml daily injection

Momenta Pharmaceuticals

Aripiprazole, multiple strengths and dosage forms

Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd.

Orphan drug designations

Tripheptinoin (Ultragenyx), UX007, for treatment of fatty acid oxidation disorders.

Tremelimumab (AstraZeneca), an anti-CTLA-4 monoclonal antibody, for the treatment of malignant mesothelioma.

Sevuparin (DF02, Dilaforette) for the treatment of patients with sickle cell disease.

IMO-8400 (Idera Pharmaceuticals), an antagonist of the endosomal Toll-like receptors (TLRs) 7, 8 and 9, to treat diffuse large B-cell lymphoma (DLBCL).

Sanguinate (Prolong Pharmaceuticals) for the treatment of sickle cell disease.

Bryostatin-1 (Neurotrope) for the treatment of Neimann Pick Disease, Type C, as well as Fragile X Syndrome.

Bardoxolone methyl (Reata Pharmaceuticals) for the treatment of pulmonary arterial hypertension.




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