Product showcase, December 2013

New formulations and generics; miscellaneous products

New approvals

  • Eslicarbazepine acetate (Aptiom—Sunovion Pharmaceuticals) is an add-on medication to treat partial seizures, the most common type of seizure seen in people with epilepsy.

  • Ibrutinib  (Imbruvica—Pharmacyclics; Janssen Biotech) treats mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer. Intended for patients who have received at least one prior therapy, ibrutinib works by inhibiting the enzyme needed by the cancer to multiply and spread. Ibrutinib is the second drug with breakthrough therapy designation to receive FDA approval and the third drug approved to treat MCL, after bortezomib (Velcade) in 2006 and lenalidomide (Revlimid) in 2013.

New formulations

  • A flavored liquid form of enalapril (Epaned—Silvergate Pharmaceuticals) treats high blood pressure in adults and in children 1 month and older. Enalapril is one of the most commonly prescribed medications in the United States for treating high blood pressure. It works by blocking a natural chemical in the body that causes blood vessels to narrow. As a result, the blood vessels relax. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
  • Diclofenac, under the brand name Zorvolex (Iroko Pharmaceuticals), is the first NSAID developed using SoluMatrix Fine Particle Technology, with dosage strengths 20% lower than currently available diclofenac products. Zorvolex contains diclofenac as submicron particles that are approximately 20 times smaller than their original size, leading to faster dissolution.
    Zorvolex was developed to address FDA’s public health advisory recommending that NSAIDs be used at the lowest effective dose for the shortest duration of time consistent with individual patient treatment goals.

New generics

  • Aciphex (rabeprazole sodium) delayed-release tablets treat gastroesophageal reflux disease in adults and adolescents 12 years or older. Dr. Reddy’s Laboratories, Kremers Urban, Lupin, Mylan, Teva, and Torrent have received FDA approval to market generic rabeprazole.
  • Capecitabine (Xeloda—Genentech), an oral chemotherapy drug, targets metastasized colorectal and breast cancers. Capecitabine has a boxed warning to alert health professionals and patients about the risk of taking a medication used to thin the blood, such as warfarin, as capecitabine could increase its effect and lead to serious adverse effects. The drug is available in 150- and 500-mg strengths.
  • Diclofenac sodium 3% gel (Impax Laboratories, Tolmar), a generic version of Solaraze Gel, is intended for topical treatment of actinic keratoses, which are small, rough, raised areas found on skin that has been exposed to the sun for a long period of time. They are usually found on the face, scalp, back of the hands, chest, or places that are often in the sun. Some actinic keratoses may develop into a type of skin cancer. Sun avoidance is indicated during therapy.
  • Dexmethylphenidate Hydrochloride Extended-Release Capsules (Mylan), the generic version of Focalin XR, is a central nervous system stimulant indicated for the treatment of ADHD.
    Dexmethylphenidate, the more pharmacologically active d-enantiomer of racemic methylphenidate, is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
  • Tetracycline HCl capsules, the generic version of Heritage Pharmaceuticals’s former brand Achromycin V, is indicated for tetracycline-sensitive infections, including respiratory, genitourinary, skin and soft tissue, and those caused by rickettsiae and Mycoplasma pneumoniae. It also is used to combat cholera, psittacosis, plague, shigellosis, and as adjunct treatment in severe acne. Tetracycline HCl capsules have been on the FDA drug shortage list for the past 2 years. The drug is available in 250- and 500-mg strengths.
  • Clonidine HCl extended-release tablets (Par Pharmaceutical), a generic version of Kapvay, is a central alpha-2 agonist for the treatment of ADHD as monotherapy or as adjunct to stimulant medications. Clonidine stimulates alpha-2 adrenergic receptors in the brain; its full mechanism of action in ADHD is not known. The tablets are available in a 0.1-mg strength.
  • Gatifloxacin ophthalmic solution 0.5%, Lupin’s generic version of Zymaxid, is a fluoroquinolone antibacterial eye drop that treats bacterial conjunctivitis. The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. The 2.5-mL solution is available in a 5-mL bottle.
  • Paricalcitol (Teva), a generic equivalent to Zemplar and an active form of vitamin D, prevents and treats secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease and in Stage 5 patients on dialysis. Capsules are available in 1-, 2-, and 4-μg strengths in 30-count bottles.


  • A radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain, Flutemetamol F 18 injection (Vizamyl—GE Healthcare/Medi-Physics) evaluates Alzheimer disease (AD) and dementia.
    The dementia caused by AD is associated with the accumulation in the brain of an abnormal protein called beta amyloid and damage or death of brain cells. However, beta amyloid can also be found in the brain of patients with other dementias and in older adults without neurologic disease.
    The drug works by attaching to beta amyloid and producing a PET image of the brain that is used to evaluate the presence of beta amyloid. A negative flutemetamol F 18 injection scan means that there is little or no beta amyloid accumulation in the brain, and the cause of the dementia is probably not due to AD. A positive scan means that there is probably a moderate or greater amount of amyloid in the brain, but it does not establish a diagnosis of AD or other dementia. The drug does not replace other diagnostic tests used to evaluate AD and dementia.


  • EPS Cold-Safe Storage Boxes (Medi-Dose) allow substances to be kept under key-security in an unlocked refrigerator. They’re easy to install yet cannot be removed if the boxes are locked. Special slotted mounting holes and brackets are easily adjustable so you can position Cold-Safe boxes within any refrigerator. Available in a variety of depths for storage versatility, Cold-Safe boxes can also be placed under cabinets, counters, utility carts, etc.