Having been granted both orphan and fast-track designation by the FDA, Retisert (fluocinolone acetonide intravitreal implant) 0.59 mg was approved for Bausch & Lomb, Rochester, N.Y., (800) 344-8815. The drug, indicated for treating chronic noninfectious uveitis affecting the posterior segment of the eye, comes as a small pellet that is surgically inserted into the eye.
NEW DRUGS Having been granted both orphan and fast-track designation by the FDA, Retisert (fluocinolone acetonide intravitreal implant) 0.59 mg was approved for Bausch & Lomb, Rochester, N.Y., (800) 344-8815. The drug, indicated for treating chronic noninfectious uveitis affecting the posterior segment of the eye, comes as a small pellet that is surgically inserted into the eye.
A new treatment for infertility is available from Ferring Pharmaceuticals, Suffern, N.Y., (845) 770-2600. Menopur (menotropins for injection, USP) is a purified human menopausal gonadotropin (hMG) indicated for the development of multiple follicles and pregnancy in patients undergoing assisted reproduction technology whose ovaries are unable to produce eggs for functional reasons. Menopur contains equal amounts of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) and is supplied in sterile vials as a lyophilized powder or pellet. Each box contains five vials of medication, five vials of diluent, and five Q.CAPs for needle-free reconstitution.
NEW FORMULATIONS Vitamin D, which helps increase the intestinal absorption of calcium, has been added to Fosamax, a product of Merck &Co., Whitehouse Station, N.J., (908) 423-1000. The FDA has approved Fosamax Plus D (alendronate sodium/cholecalciferol) in a single once-weekly tablet as a treatment for postmenopausal women with osteoporosis. The new formulation contains 70 mg Fosamax and 2800 IU vitamin D3. Fosamax helps reduce the risk of hip and spine fractures, and is claimed to be the only bisphonphonate with the added benefit of a weekly dose of vitamin D. It is also indicated to increase bone mass in men with osteoporosis.
Mylan Laboratories has been given tentative approval for a generic version of Novartis Pharmaceuticals' Lamisil Tablets. Terbinafine hydrochloride tablets will be available in 250-mg strength for treating onychomycosis of the toenails and fingernails caused by dermatophytes. Mylan is headquartered in Pittsburgh, at (724) 514-1800.
A generic version of Sanofi-Aventis' Allegra-D 12 Hour Extended-Release Tablets has been approved for Barr Laboratories, Woodcliff Lake, N.J., (800) 222-0190. Fexofenadine HCl (60 mg) and pseudoephedrine HCl (120 mg) extended-release tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older.
Approval for anagrelide hydrochloride capsules 0.5 mg and 1 mg has been granted to five drugmakers. In addition to Barr Laboratories and Mylan Pharmaceuticals, Eon Laboratories, Lake Success, N.Y., (516) 478-9700; Impax Laboratories, Hayward, Calif., (510) 476-2000; and Roxane Laboratories, Columbus, Ohio, (614) 272-4774, will market this generic version of Agrylin, from Shire Pharmaceutical Group. The platelet-reducing agent is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms, including thrombo-hemorrhagic events.
New formulations of Schering-Plough's Elocon Topical Lotion have received FDA approval. Israel-based Agis Industries, a subsidiary of Perrigo Co., Allegan, Mich., (269) 673-945, will manufacture and market mometasone furoate topical solution USP, 0.1% (lotion). Fougera, Melville, N.Y., (800) 645-9833, has received approval for mometa-sone furoate cream 0.1% and mometasone furoate ointment USP 0.1%, both of which will be available in 15- and 45-gm tubes. The agent is indicated for the relief of inflammatory skin conditions.
Alpharma Inc., Fort Lee, N.J., (201) 947-7774; Andrx Corp., Ft. Lauderdale, Fla., (800) 621-7143; and TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA, are introducing metformin hydrochloride extended-release tablets in 750-mg strength. The agent provides a generic alternative to Bristol-Myers' Squibb's Glucophage XR tablets in the same strength, indicated as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes.
OTC Fleet Phospho-soda, a bowel-cleansing agent to prepare the colon for surgery, X-ray, or endoscopic examination, is being converted from 3-fl. oz. to 1.5-fl. oz bottles to simplify dosing for the two 1.5-fl. oz. doses that are to be separated by 10 to 12 hours. The product is manufactured by C. B. Fleet Co., Lynchburg, Va., (434) 528-4000.