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FDA Drug Approvals: April 2014


FDA actions in brief, fast-track designation, orphan drug designation, first-time generic approvals

FDA actions in brief

• Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract (Oralair, Stallergenes S.A and Greer Labs) sublingual allergy immunotherapy was approved as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for grass pollen-specific IgE antibodies for any of the 5 grass species contained in the product. It is approved for use in persons aged 10 through 65 years. 

  • Topiramate (



Janssen Pharmaceuticals

) was approved for prevention (prophylaxis) of migraine headaches in adolescents aged 12 to 1 years. This is the first FDA approval of a drug for migraine prevention in this age group.

• Coagulation Factor IX (Recombinant), Fc Fusion Protein (Alprolix, Biogen Idec) was approved for use in adults and children who have hemophilia B. It is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

• Apremilast (Otezla, Celgene), an oral, selective inhibitor of phosphodiesterase 4 (PDE4), was approved for the treatment of adult patients with active psoriatic arthritis.

• Topiramate (Qudexy XR, Upsher-Smith Laboratories) was approved for initial monotherapy in patients aged 10 years and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures. It is also approved as adjunctive therapy in patients aged 2 years and older with POS, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome.

• Apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) was approved for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip- or knee-replacement surgery.

• A new formulation of posaconazole (Noxafil, Merck) injection (18 mg/mL) was approved for intravenous use for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

• A new indication for omalizumab (Xolair, Genentech and Novartis) was approved for chronic idiopathic uyrticaria, a form of chronic hives, in patients aged 12 years and older who remain symptomatic despite treatment with H1-antihistamine therapy.

• Oxycodone HCl and acetampinophen (Xartemis XR, Mallinckrodt) extended release oral formulation was approved for the management of acute pain in patients requiring opioid treatment and for whom alternative therapies are inadequate, ineffective, or are not tolerated.

• F-18 florbetaben (Neuraceq,Piramal Imaging) was approved as a diagnostic amyloid agent to help rule out Alzheimer’s disease.


Fast-track designation

• EPI-743 (Edison Pharmaceuticals) for the treatment of Friedreich’s ataxia.

• Bavituximab (Peregrine Pharmaceuticals) for the potential treatment of second-line non-small cell lung cancer (NSCLC).


Orphan drug designation

•Flammacerium (Sinclair IS Pharma) for the treatment of patients with severe dermal burns.


First-time generic approvals

• Atovaquone (equiv to Monodox) in 50 mg/5 mL oral suspension


• Raloxifene (equiv to Evista) in 60-mg tablets


• Carbidopa (equiv to Lodosyn) in 25-mg tablets

Amerigen Pharmaceuticals

• Ciprofloxacin (equiv to Cipro) in 250 mg/5 mL and 500 mg/5 mL oral suspension formulation











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