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FDA drug approvals: March 2014


FDA actions in brief, breakthrough therapy designations, priority review, fast-track designations, orphan drug designations

Actions in brief

Hyaluronate acid injection (Monovisc, Anika Therapeutics) was approved for the treatment of pain and improve joint mobility in patients with osteoarthritis of the knee. It is the first FDA-approved single-injection product with HA from a non-animal source.

Metreleptin for injection (Myalept, Amylin Pharmaceuticals) was approved as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.

Ivacaftor (Kalydeco, Vertex Pharmaceuticals) was approved for patients with cystic fibrosis aged 6 years and older who have 1 of 8 additional mutations in the cystic fibrosis transmembrane conductance regulator gene.

Droxidopa (Northera, Chelsea Therapeutics) was approved for the treatment of neurogenic orthostatic hypotension.

Elosulfase alfa (Vimizim, BioMarin Pharmaceuticals) was approved for the treatment of Mucopolysaccharidosis Type IV A (Morquio A syndrome).

Ibrutinib (Imbruvica, Pharmacyclics) was approved for the treatment of patients with chronic lymphocyctic leukemia who have received at least 1 previous therapy.



Complete response

Posidur (SABER-Buprivacaine, DURECT), an investigational drug for administration into the surgical site to produce post-surgical analgesia. FDA said it cannot approve the New Drug Application in its present form because it does not contain enough information to show that the drug is safe when used in the manner described in the proposed label. FDA has indicated that additional clinical safety studies are needed. DURECT is evaluating the issues brought up by FDA and plans to have further discussions with the Agency.

Breakthrough therapy designation

Declatasvir and asunaprevir dual regimen (Bristol-Myers Squibb) for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection.

Priority review

Belinostat (Beleodaq, Spectrum Pharmaceuticals) for injection, a novel pan-HDAC inhibitor for the treatment of patients with relapsed or refractory periperhal T-cell lymphoma.

Oritavancin (The Medicines Company), an investigational intravenous antibiotic for the treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria, such as methicillin-resistant Staphylococcus areaus.

Fast-track designations

TKM-Ebola (Tekmira Pharmaceuticals) for the treatment of Ebola virus.

GLYX-13 (Naurex) as an adjunctive therapy in major depressive disorder.

Egalet-001 abuse-deterrent, extended-release formulation and Egalet-002 abuse-deterrent, extended-release, oral oxycodone formulation (Egalet) for the treatment of moderate-to-severe pain.



Orphan-drug designations

Marizomib (Triphase Accelerator Corp.), a novel potent proteasome inhibitor for the treatment of multiple myeloma.

Gevokizumab (XOMA) IL-1 beta modulating antibody for the treatment of pyoderma gangrenosum.

KRN5500 (Dara BioSciences) novel, non-opioid, non-narcotic intravenous product for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics.


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