Cephalon Inc., Frazer, Pa., (610) 344-0200, has approval from the FDA to market Fentora (fentanyl buccal tablet) C-II. The opioid agonist, available in strengths of 100, 200, 400, 600, and 800 mcg, is indicated for the management of breakthrough pain in cancer patients who are already receiving and who are tolerant to opioid therapy for underlying, persistent cancer pain. Cephalon's OraVescent drug delivery system allows much of the medication to be absorbed directly across the lining of the upper cheek and into the bloodstream.
There is a newly approved use for Lamictal (lamotrigine) Tablets, from GlaxoSmithKline, Research Triangle Park, N.C. The anti-seizure medication is now indicated for the treatment of the primary generalized tonic-clonic (PGTC) seizures of epilepsy. The approval allows the drug to be used as add-on therapy to treat PGTC seizures in children aged two and older as well as adults. GSK can be reached at (919) 483-2100.
A new indication has also been approved for Remicade (infliximab), from Centocor Inc., Horsham, Pa., (610) 651-6000, for adult patients with chronic severe plaque psoriasis—that which is extensive and/or disabling. The recommended dose of this anti-TNF-alpha treatment is an infusion of 5 mg/kg followed by additional doses at two and six weeks following, then every eight weeks thereafter.
For South San Francisco-based Genentech Inc., (650) 225-1000, and Biogen Idec, Cambridge, Mass., (617) 679-2000, the FDA has approved two new indications for Rituxan (rituximab) for patients with CD20-positive, B-cell, non-Hodgkin's lymphoma (NHL). One new use is for first-line treatment of previously untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine, and prednisolone) chemotherapy. The other new indication is for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
Fort Worth-based Alcon Laboratories, (817) 293-0450, has received approval for Travatan Z (travoprost ophthalmic solution) 0.004%. This new formulation is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are intolerant of or who have not responded to other IOP-lowering medications.
A new 25-mg strength is available in a line of proprietary prescription vaginal suppository unit-of-use compounding kits from CutisPharma Inc., Beverly, Mass., (978) 867-1010. FIRST Progesterone VGS 25 includes premeasured, preweighed bioidentical progesterone and a suppository mold for compounding by a pharmacist. Kits are also available in strengths of 50, 100, and 200 mg.
Stiefel Laboratories, Coral Gables, Fla., (888) 784-3335, has available a new, larger 140-gm tube of prescription MimyX Cream. The steroid-free topical medication is indicated for managing the signs and symptoms of various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. The cream was already available in a 70-gm tube.