Product showcase, July 2013

New approvals, indication, generics

New approvals

  • Sanofi has received FDA approval for its quadrivalent influenza vaccine (Fluzone Quadrivalent) for use in children 6 months of age and older, adolescents, and adults.
    The 2013–14 flu season will be the first season in which quadrivalent influenza vaccines will be available in the United States. Until this year, seasonal influenza vaccines included only one B strain. The quadrivalent vaccine includes two A strains and two B strains to help protect against influenza.
    The vaccine will be available in prefilled syringes and single-dose vials for intramuscular administration. Health care providers wishing to reserve the vaccine can do so by visiting or by calling 800-822-2463.
  • Flamel Technologies announced FDA approval of neostigmine methylsulfate (Bloxiverz), an I.V. drug used in the operating room to reverse the effects of nondepolarizing neuromuscular blocking agents after surgery.
    Bloxiverz is the first FDA-approved version of neostigmine, although other versions of neostigmine have been on the market as unapproved, grandfathered products under the Food, Drug, and Cosmetic Act of 1938. Unapproved versions of neostigmine have been in short supply for nearly a year, according to Flamel Technologies.
    The most common adverse reactions to neostigmine include bradycardia, nausea, and vomiting. Atropine or glycopyrrolate should be administered prior to neostigmine to minimize the risk of bradycardia. The drug should be used with caution in patients with arrhythmias, recent acute coronary syndrome, vagotonia, hyperthyroidism, myasthenia gravis, epilepsy, or peptic ulcer. Because of the possibility of hypersensitivity, atropine and medications to treat anaphylaxis should always be readily available.
    Flamel expects to launch the drug in July 2013 in 0.5- and 1.0-mg/mL strengths.

New indication

  • FDA has approved lenalidomide (Revlimid—Celgene Corporation) for the treatment of mantle cell lymphoma (MCL) that has relapsed or progressed after two prior therapies, one of which included bortezomib.
    Approval was based on a single-arm, multicenter clinical trial enrolling 134 patients with MCL who had relapsed after or were refractory to bortezomib or a bortezomib-containing regimen. Patients had received a median of four prior therapies for MCL.
    The recommended dose and schedule for lenalidomide is 25 mg orally once daily on days 1–21 of repeated 28-day cycles. Lenalidomide should be taken at about the same time each day, either with or without food.
    This supplemental application also included the approval of a new 20-mg capsule strength.
  • FDA has approved denosumab (Xgeva—Amgen) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually noncancerous tumor. Denosumab was approved in 2010 to prevent fractures when cancer has spread to the bones.
    Denosumab is a monoclonal antibody that binds to RANKL, a protein essential for maintenance of healthy bone. RANKL is also present in GCTB. Denosumab is intended for patients whose GCTB cannot be surgically removed or when surgery is likely to result in severe morbidity, such as loss of limbs or joint removal. It should only be used in adolescents whose bones have matured.
    In clinical studies, common adverse effects included joint pain (arthralgia), headache, nausea, fatigue, back pain, and extremity pain. The most common serious adverse effects were osteonecrosis of the jaw and osteomyelitis. Women of reproductive potential should use highly effective contraception while taking denosumab because of potential fetal harm.

New generics

  • Dr. Reddy’s Laboratories announced FDA approval of zoledronic acid injection, an AP-rated generic version of Novartis’s Reclast. Zoledronic acid injection is a bisphosphonate used to treat postmenopausal osteoporosis, to reduce the incidence of new clinical fractures in patients at high risk of fractures, and to increase bone mass in men with osteoporosis. It is also used to treat Paget disease and to treat and prevent glucocorticoid-induced osteoporosis in patients who are expected to be on glucocorticoids for 12 months or longer.
    Zoledronic acid injection will be available in a 5-mg, 100-mL strength in single-use vials for I.V. infusion.
  • InnoPharma announced FDA approval of cosyntropin injection, a generic of Amphastar’s Cortrosyn, a synthetic adrenocorticotropic hormone (ACTH) used to screen patients for adrenocortical insufficiency. Cosyntropin acts similarly to purified natural ACTH and produces maximal secretion of 17-OH corticosteroids, 17-ketosteroids, and/or 17-ketogenic steroids.
    InnoPharma’s cosyntropin injection will be available in a 0.25-mg/vial strength in single-use vials.
  • Mylan announced that FDA has approved zolmitriptan, an AB-rated generic version of Zomig (Impax Laboratories), for the acute treatment of migraine with or without aura in adults.
    Zolmitriptan is for use only with a clear diagnosis of migraine. If a patient does not respond after the first dose, the health care provider should reconsider the diagnosis before readministering. The product is not indicated for the prevention of migraine attacks or cluster headaches.
    Mylan has already begun shipping zolmitriptan tablets in 2.5- and 5-mg strengths.
  • Teva Pharmaceuticals announced the release of levalbuterol inhalation solution, an AN-rated generic version of Sunovion Pharmaceuticals’ Xopenex. Levalbuterol is a beta-2 agonist for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years or older who have reversible obstructive airway disease.
    Levalbuterol inhalation solution is available in 0.31-, 0.63-, and 1.25-mg strengths in 3-mL vials.