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New products (Rx, OTC, HBC, HHC, and ETC.) for DRUG TOPICS, September 13, 2004
Sanctura (trospium chloride tablets), a product of Indevus Pharmaceuticals, Lexington, Mass., (781) 861-8444, and PLIVA subsidiary Odyssey Pharmaceuticals, is now available in U.S. pharmacies. The recently FDA-approved drug is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The FDA has approved two new drugs for treating internal contamination from radioactive elements. Contamination can result from a laboratory accident or release of a "dirty bomb," and can occur by ingestion, inhalation, or direct contact through an open wound. Ca-DTPA (pentetate calcium trisodium injection) and Zn-DTPA (pentetate zinc trisodium injection) increase the rate of elimination of plutonium, americium, or curium by the body. Since Ca-DTPA is more effective than Zn-DTPA during the first 24 hours following contamination, Ca-DTPA should be the first choice for first-dose administration if both agents are available. The drugs are usually administered into the bloodstream but can be administered by nebulized inhalation. Both drugs are sponsored by the German firm Hameln Pharmaceuticals GmbH and will be available through U.S. pharmacies by prescription. For further information, call (800) INFO-FDA.
Approved for a new indication is Lipitor (atorvastatin calcium), from Pfizer Inc., New York City, (212) 733-2323. The cholesterol-lowering agent can now be used for the prevention of cardiovascular disease by reducing heart attack risk in people with normal to mildly elevated cholesterol levels who also have other cardiovascular risk factors.
Boehringer Ingelheim Corp., Ridgefield, Conn., (203) 798-9988, has received FDA approval to use MOBIC (meloxicam) tablets for the management and treatment of rheumatoid arthritis. The nonsteroidal anti-inflammatory drug was already approved for use in relieving the signs and symptoms of osteoarthritis. MOBIC is comarketed with Abbott Laboratories.
An expanded indication has been granted to Abbott Laboratories, Abbott Park, Ill., (800) 255-5162, for Humira (adalimumab). The rheumatoid arthritis drug can now be used to improve physical function, and thus quality of life, for adult patients with moderately to severely active RA.
Taxotere (docetaxel), a product of Aventis Pharmaceuticals, Bridgewater, N.J., (800) 207-8049, is already used to treat advanced breast cancer patients after failure of prior chemotherapy. Taxotere Injection Concentrate, in combination with doxorubicin and cyclophosphamide, has now been given clearance for adjuvant, postsurgical treatment of patients with operable, node-positive breast cancer. Earlier use of this agent has been shown to significantly improve disease-free survival by reducing the risk of relapse in these patients.
Eli Lilly, Indianapolis, (317) 277-6583, has a second approved indication for its anticancer drug Alimta (pemetrexed): the treatment of locally advanced or metastatic non-small cell lung cancer in previously treated patients. The drug was approved earlier for treatment, in combination with cisplatin, of malignant pleural mesothelioma.
The FDA has approved a new indication for the antiseizure medication Topamax. Ortho-McNeil Pharmaceutical, Raritan, N.J., (800) 682-6532, can now market Topamax (topiramate) Tablets and Topamax (topiramate capsules) Sprinkle Capsules for the prevention of migraine headaches in adults. The drug was already approved as adjunctive therapy for adults and children ages two to 16 with partial-onset seizures or primary tonic-clonic seizures and in patients two years of age and older with Lennox-Gastaut syndrome.
A new dosage strength of metolazone tablets USP is available from TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA-USA. A 5-mg tablet of the quinazoline-class diuretic/saluretic/antihypertensive drug has been added to the already available 2.5- and 10-mg strengths. Metolazone is indicated for the treatment of salt and water retention, including edema accompanying congestive heart failure and edema accompanying renal diseases; and for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. Metolazone tablets offer a generic alternative to Celltech's Zaroxolyn tablets.
Aventis Pharmaceuticals has approval for a new, reusable pen for injecting Lantus (insulin glargine [rDNA origin] injection), a 24-hour basal insulin analog. OptiClik offers an integrated system of insulin delivery for patients with Type 1 and Type 2 diabetes. Lantus is indicated for once-daily subcutaneous administration of insulin for adult patients with Type 2 diabetes and for adult and pediatric patients six years of age and older with Type 1 diabetes.
PLIVA Inc., East Hanover, N.J., (973) 386-5566, has received FDA approval for two new generic medications. Propafenone HCl tablets provide a generic alternative to Rythmol, a product of Helopharm W. Petrik GmbH & Co. KG. The antiarrhythmic drug is available in 150-, 225-, and 300-mg strengths, each one in bottles of 100. It is indicated for treating paroxysmal atrial fibrillation and paroxysmal supraventricular tachycardia in patients without structural heart disease; it is used as well to treat documented, life-threatening ventricular arrhythmias. Torsemide tablets, offering a generic equivalent to Roche Therapeutics' Demadex, is a diuretic indicated for treating edema associated with congestive heart failure, renal disease, or hepatic disease. The tablets are available in 5-, 10-, and 20-mg strengths in bottles of 100.
A generic alternative to Medicis' Loprox has been approved for Fougera, Melville, N.Y., (800) 645-9833. Ciclopirox Topical Suspension USP, 0.77%, is available in 30- and 60-ml bottles. The broad-spectrum antifungal agent is indicated in the treatment of various dermal infections, including tinea pedis, tinea cruris, and tinea corporis due to various fungal species.
Taro Pharmaceutical Industries, Hawthorne, N.Y., (800) 544-1449, has received approval for several new generics. Alclometasone dipropionate ointment, USP 0.05%, used for treating inflammatory skin diseases, is a low- to medium-potency topical corticosteroid that is bioequivalent to GlaxoSmithKline's Aclovate ointment. Fluconazole tablets have been approved in four strengths: 50, 100, 150, and 200 mg. Bioequivalent to Pfizer's Diflucan, the antifungal product is used to treat candidiasis affecting various parts of the body as well as cryptococcal meningitis. C/B Lotion (clotrimazole and betamethasone dipropionate lotion) combines a topical corticosteroid and an antifungal to treat inflammatory fungal infections of the skin (including athlete's foot). C/B lotion provides a generic alternative to Schering's Lotrisone lotion.
American Pharmaceutical Partners, Schaumberg, Ill., (847) 969-2700, has final approval for two new generics. Tobramycin for injection, USP, is a freeflowing powder consistent with the innovator product Nebcin, from Eli Lilly. It is used to treat various infections, including septicemia, lower respiratory tract infections, serious central nervous system infections, intra-abdominal infections, and recurrent urinary tract infections. Methylprednisolone sodium succinate for injection, USP, in a 40-mg (base)/ vial and 125-mg (base)/vial, provides a generic alternative to Pfizer's Solu-Medrol and Abbott Laboratories' A-Methapred. The anti-inflammatory agent is indicated in the treatment of various conditions, including endocrine and rheumatic disorders, ophthalmic and dermatologic diseases, and allergic and edematous states. For Esmolol hydrochloride injection, 10 mg/mL, there is tentative approval. The generic equivalent of Brevibloc Injection, from Baxter International, esmolol is a short-acting agent indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or emergency situations.
Baxter Healthcare Corp., Deerfield, Ill., (847) 948-2000, has FDA approval for fluconazole injection, a generic alternative to Pfizer's injectable Diflucan. The antifungal is used in treating serious fungal (Candida) infections. Baxter's fluconazole comes premixed in a flexible container for immediate use. The formulation is available as 200 mg/100 mL in sodium chloride 0.9% injection, and 400 mg/200 mL in sodium chloride 0.9% injection.
The ANDA for nicotine polacrilex gum, mint flavor from Watson Pharmaceuticals, Corona, Calif., (909) 270-1400, has been approved. This generic version of GlaxoSmithKline Consumer Healthcare's Nicorette Mint gum is indicated as an aid to smoking cessation. It is available in 2 and 4 mg.
Roxane Laboratories, Columbus, Ohio, (614) 272-4774, is introducing generic Clotrimazole Troches, a synthetic antifungal lozenge for the local treatment of oropharyngeal candidiasis. AB-rated to Mycelex Troches, from Bayer-Roche L.L.C., each troche contains 10 mg clotrimazole. The product is available in bottles of 70 and 140 tablets and seven strips of 10 unit-dose blister cards.
The FDA has approved generic atenolol tablets, USP, in 25-, 50-, and 100-mg strengths. Able Laboratories, South Plainfield, N.J., (908) 754-2253, is the manufacturer of the antihypertensive drug. The product is therapeutically equivalent to AstraZeneca's Tenormin. It is used in the treatment of high blood pressure, the long-term management of patients with angina pectoris, and the management of patients with suspected acute myocardial infarction.
A 40-gm vial of piperacillin for injection, USP, in a pharmacy bulk pack has been approved for American Pharmaceutical Partners. The third-generation antibiotic provides a generic alternative to Wyeth's Pipracil. It is indicated for treating serious infections caused by designated susceptible microorganisms, such as P. aeruginosa (pseudomonas), and is active against a variety of gram-positive and gram-negative aerobic and anaerobic bacteria. The 2-, 3-, and 4-gm single-dose vials of piperacillin were approved earlier.
For nonantibiotic management of topical acne, there is dermatologist-recommended Nicomide-T, from Sirius Laboratories, Vernon Hills, Ill., (847) 968-2424. This "behind-the-counter" product, in both cream and gel, contains nicotinamide and nicotinic acid, water-soluble components of the vitamin B complex. According to the company, Nicomide-T is nonirritating, is not a cause of photosensitivity, and may improve tolerability of concomitantly administered retinoids and benzoyl peroxides. The gel formulation is suited to oilier skin.
CORRECTION: There was an error in the company citation for MUCINEX DM in the Aug. 9 New Product Newswire. The name of the manufacturer is: Adams Respiratory Therapeutics, Chester, N.J., (800) 974-3477.
Nancy Jillard. New Product Newswire. Drug Topics Sep. 13, 2004;148:70.