- Resource Centers
Fentora (fentanyl buccal tablet)
Marketed by: Cephalon Inc (Frazer, Pa)
Indication: September 25, 2006?Cephalon received approval from the FDA to market Fentora (CII) for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Fentora is the first and only buccal tablet approved for this indication.
Dosage Form: Tablets: 100, 200, 400, 600, and 800 mcg
For More Information: www.cephalon.com 800-896-5855
FluLaval (influenza virus vaccine)
Marketed by: GlaxoSmithKline (Philadelphia, Pa)
Indication: October 5, 2006?The FDA approved FluLaval, under fast-track review status, for the active immunization of adults 18 years of age and older against influenza disease caused by influenza virus types A and B. The approval of FluLaval is a major step toward increasing the supply of flu vaccine.
Dosage Form: 10 0.5-mL doses in a 5-mL vial
For More Information: www.gsk.com 888-825-5249
Marketed by: GlaxoSmithKline (Research Triangle Park, NC)
Indication: September 25, 2006?The FDA approved a new indication for the antiseizure medicine Lamictal. Lamictal tablets may now be used to treat primary generalized tonic-clonic (PGTC) seizures (also known as "grand mal" seizures). The tablets are indicated as add-on therapy to treat PGTC seizures in children aged 2 and older, as well as adults. Lamictal is also approved as maintenance therapy for adults with bipolar I disorder.
Dosage Form: Tablets: 25, 100, 150, and 200 mg
For More Information: www.gsk.com 888-825-5249
Marketed by: Schering-Plough (Kenilworth, NJ)
Indication: September 18, 2006?The FDA approved Noxafil Oral Suspension for the prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versushost disease, or those with hematologic malignancies with prolonged neutropenia from chemotherapy. This represents the first and only approval for an antifungal agent used to prevent invasive fungal infections caused by Aspergillus species.
Dosage Form: Oral suspension: 200 mg/5 mL
For More Information: www.schering-plough.com 908-298-4000
Marketed by: Centocor Inc (Horsham, Pa)
Indication: September 27, 2006?The FDA approved an additional indication for Remicade?for the treatment of adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. Remicade is the first and only anti-tumor necrosis factor-alpha treatment to receive 13 FDA approvals for inflammatory diseases across gastroenterology, rheumatology, and dermatology.
Dosage Form: Sterile, white, lypholized concentrate containing 100 mg infliximab in a single-use vial
For More Information: www.remicade.com 888-779-9769
Marketed by: Janssen LP (Titusville, NJ)
Indication: October 6, 2006?The FDA approved Risperdal, an adult antipsychotic oral tablet, for the symptomatic treatment of irritability in autistic children and adolescents. This approval represents the first use of a drug to treat behaviors associated with autism in children.
Dosage Form: Tablets: 0.25, 0.5, 1, 2, 3, and 4 mg
For More Information: www.risperdal.com 800-526-7736
Marketed by: Amgen Inc (Thousand Oaks, Calif)
Indication: September 27, 2006?The FDA approved Vectibix after priority review. Vectibix is the first entirely human monoclonal antibody for the treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal cancer after disease progression while on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Dosage Form: Sterile, colorless, preservative-free solution containing 20 mg/mL panitumumab in a single-use vial
For More Information: www.amgen.com 800-772-6436
Verdeso (desonide) Foam, 0.05%
Marketed by: Connetics Corp (Palo Alto, Calif)
Indication: September 20, 2006?Connetics Corp announced FDA approval of Verdeso Foam, 0.05%, for the treatment of mild-to-moderate atopic dermatitis. The product, previously known as Desilux, is a low-potency topical steroid and is the first approved product formulated in Connetics' proprietary VersaFoam-EF emulsion formulation foam vehicle.
Dosage Form: 50 and 100 g
For More Information: www.connetics.com 888-969-2628
Xolegel (ketoconazole, USP) Gel, 2%
Marketed by: Barrier Therapeutics Inc (Princeton, NJ)
Indication: July 28, 2006?Xolegel gel, 2%, was approved by the FDA for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older. Xolegel, formerly known as Sebazole, is a topical formulation of 2.0% ketoconazole, an antifungal agent, in a waterless gel for once-daily application. Xolegel is the first prescription gel formulation of ketoconazole approved in the United States.
Dosage Form: Gel: 2-g sample tube; 15-g aluminum tube
For More Information: www.barriertherapeutics.com 866-440-5508
YAZ (3 mg drospirenone/20 mcg ethinyl estradiol)
Marketed by: Berlex Inc (Wayne, NJ)
Indication: October 5, 2006?The FDA has approved YAZ as the first and only oral contraceptive shown to be clinically effective for the treatment of emotional and physical symptoms of premenstrual dysphoric disorder in women who choose to use an oral contraceptive. YAZ, approved for the prevention of pregnancy in March 2006, is the first birth-control pill to combine ethinyl estradiol with the innovative progestin drospirenone in a 24-day active hormone pill regimen.
Dosage Form: Tablets: 24 active tablets (3 mg drospirenone/20 mcg ethinyl estradiol) and 4 inert tablets
For More Information: www.berlex.com 888-237-5394