Rx Product News
KAPVAYMarketed by: Shionogi Pharma Inc (Atlanta, GA)
Indication: The FDA recently approved Kapvay (clonidine hydrochloride) extendedrelease tablets for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years. Kapvay is the only formulation of clonidine hydrochloride approved by the FDA for the treatment of ADHD, and the first FDAapproved ADHD treatment indicated for use as add-on therapy to stimulant medication. Kapvay can also be used as monotherapy when treating ADHD. Clonidine stimulates alpha2-adrenergic receptors in the brain but its exact mechanism of action iN ADHD is not known. Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine. Dosage Form: Extended-release tablets: 0.1 and 0.2 mg
For More Information: www.kapvay.com
Bristol-Myers Squibb (Princeton, NJ)
Indication: Sprycel (dasatinib) has received FDA approval for the treatment of adults with the rare Philadelphia chromosome— positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. An oral kinase inhibitor, Sprycel was approved in 2006 for the treatment of other forms of CML with resistance to or intolerance of standard therapies, including imatinib, as well as for the treatment of Ph+ acute lymphoblastic leukemia with resistance to or intolerance of prior therapies. Sprycel should be used with caution in patients with hepatic impairment.
Dosage Form: Tablets: 20, 50, 70, 80, 100, and 140 mg
For More Information: www.sprycel.com
PristiqMarketed by: Wyeth Pharmaceuticals Inc (Philadelphia, PA)
Indication: The FDA recently approved labeling changes to Pristiq (desvenlafaxine), a structurally novel, once-daily serotonin and norepinephrine reuptake inhibitor for the treatment of adult patients with major depressive disorder. The changes state that discontinuation symptoms have been reported when switching patients from other antidepressants, including venlafaxine, to Pristiq. Tapering of the initial antidepressant may be necessary to minimize these symptoms. When discontinuing treatment, gradual dose reduction is also recommended whenever possible. Pristiq is approved as a once-daily 50-mg dose that does not require titration.
Dosage Form: Tablets: 50 and 100 mg
For More Information: www.pristiq.com
CymbaltaMarketed by: Eli Lilly and Co (Indianapolis, IN)
Indication: The FDA recently approved Cymbalta (duloxetine HCl) for the management of chronic musculoskeletal pain, including osteoarthritis and chronic lower back pain. Cymbalta had previously been approved for treatment of major depressive order, generalized anxiety disorder, diabetic peripheral neuropathy, and fibromyalgia. Although the exact mechanism of action of Cymbalta is unknown, duloxetine is a potent inhibitor of neuronal serotonin and norepinephrine reuptake. The recommended starting dose for treatment of musculoskeletal pain is 60 mg once daily. Patients can be given a starting dose of 30 mg once daily for 1 week before increasing to 60 mg once daily.
Dosage Form: Capsules: 20, 30, and 60 mg
For More Information: www.cymbalta.com
BromdayMarketed by: ISTA Pharmaceuticals Inc (Irvine, CA)
Indication: The FDA approved Bromday (bromfenac ophthalmic solution) 0.09%, the first and only once-daily ophthalmic nonsteroidal antiinflammatory drug for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Each mL of Bromday contains 1.035 mg bromfenac sodium. One drop of Bromday should be applied to the affected eye(s) once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days of the postoperative period.
Dosage Form: Topical ophthalmic solution: bromfenac 0.09%
For More Information: www.istavision.com/products/bromday.html
EgriftaMarketed by: EMD Serono Inc (Rockland, MA)
Indication: EMD Serono Inc, an affiliate of Merck KGaA, announced the FDA approval of Egrifta (tesamorelin for injection). Egrifta is the first and only treatment indicated to reduce excess abdominal fat in HIV-infected patients with lipodystrophy. The product is not indicated for weight loss management. Because the long-term cardiovascular safety and benefit of Egrifta have not been studied, careful consideration should be given whether to continue treatment in patients who do not show a clear efficacy response. The recommended dose is 2 mg injected subcutaneously into the abdomen once daily.
Dosage Form: Egrifta is supplied in a vial containing 1 mg of tesamorelin as a lyophilized powder. The diluent (Sterile Water for Injection, 10 mL) is provided in a separate vial.
For More Information: www.egrifta.com