Valera Pharmaceuticals, Cranbury, N.J., (888) 262-8855, has approval to market the Vantas implant, designed for the continuous 12-month administration of histrelin, a gonadotropin-releasing hormone analog similar to one normally released from the hypothalamus gland. The long-acting implant will be used to treat locally advanced and metastatic prostate cancer.
NEW DRUGS Valera Pharmaceuticals, Cranbury, N.J., (888) 262-8855, has approval to market the Vantas implant, designed for the continuous 12-month administration of histrelin, a gonadotropin-releasing hormone analog similar to one normally released from the hypothalamus gland. The long-acting implant will be used to treat locally advanced and metastatic prostate cancer.
From Serono Inc., Rockland, Mass., (800) 283-8088, comes Luveris (lutropin alfa), a product of recombinant DNA technology. It is indicated for use in combination with a recombinant follicle-stimulating hormone to induce ovulation in infertile women with severe deficiencies of luteinizing hormone and FSH.
NEW INDICATIONS The FDA recently approved a new indication for Caduet (amlodipine besylate/atorvastatin calcium) from Pfizer Inc., New York City, (212) 733-2323. Caduet, which is a combination of Lipitor and Norvasc and is already approved for treating high blood pressure and high cholesterol, is now indicated to prevent heart disease and lower the risk of heart attack in people with hypertension and other risk factors but with normal cholesterol levels.
Merck & Co., Whitehouse Station, N.J., (908) 423-1000, has obtained FDA clearance for a new indication for Cancidas (caspofungin acetate). The drug can now be used as empirical therapy for presumed fungal infections in febrile neutropenic patients. Cancidas was approved earlier for the treatment of invasive aspergillosis in patients intolerant of or unresponsive to other antifungal treatments, for first-line treatment of Candida infections, and for treating esophageal candidiasis.
NEW DOSING STRENGTH Norditropin NordiFlex (somatropin [rDNA] injection), a premixed, prefilled, multidose, disposable hGH pen, can now be used for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. Novo Nordisk, Princeton, N.J., (800) 727-6500, is the developer of the fully integrated delivery system for human growth hormone. Norditropin NordiFlex is prefilled so there is no loading of cartridges.
NEW GENERICS Two companies have received FDA approval for carboplatin for treating advanced ovarian cancer. American Pharmaceutical Partners, Schaumberg, Ill., (847) 969-2700, has FDA approval for carboplatin for injection, USP (50 mg, 150 mg, and 450 mg), the lyophilized form of carboplatin, as well as carboplatin injection multidose vials, the liquid form (50 mg/5mL, 150 mg/15 mL, and 450 mg/45 mL) ... Mayne Pharma, Paramus, N.J., (201) 225-5500, holds approval for carboplatin injection in 50 mg/5mL, 150 mg/15 mL, and 450 mg/45 mL. The approval provides generic equivalents to Bristol-Myers Squibb's Paraplatin. The drug is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents, as well as for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy.
Approval has been given to three drugmakers for flumazenil injection: American Pharmaceutical Partners; Apotex Corp., Weston, Fla., (800) 706-5575; and Sicor Inc., Irvine, Calif., (800) 729-9992. The product is a generic equivalent of Roche Laboratories' Romazicon Injection, indicated for complete or partial reversal of the sedative effects of benzodiazepines and for the management of benzodiazepine overdose.
Roxane Laboratories, Columbus, Ohio, has received approval for mefloquine hydrochloride tablets 250 mg, offering a generic alternative to Roche's Lariam. Mefloquine is an oral agent used in the treatment and prevention of malaria caused by Plasmodium falciparum or P. viva.
Gabapentin capsules are available from Teva Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA. The capsules, in 100-, 300-, and 400-mg strengths, offer a generic alternative to Pfizer's Neurontin. Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy and as adjunctive therapy in the treatment of partial seizures in pediatric patients ages three to 12 years.