Magazine article Drug Topics

New Product Newswire

Magazine article Drug Topics

New Product Newswire

Article excerpt



Approved in November, Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) is now available to women to prevent pregnancy. Ortho-McNeil Pharmaceutical, Raritan, N.J., claims it is the first birth control patch to be approved by the FDA. When replaced weekly, the hatch offers 99% efficacy when used appropriately. For more information, call (877) BCPATCH.


Paxil CR (paroxetine HCl) Controlled Release, a product of GlaxoSmithKline, Philadelphia, (888) 825-5249, offers a new formulation of GSK's serotonin reuptake inhibitor Paxil. Paxil CR combines the efficacy of paroxetine with an advanced technology that controls dissolution and absorption of the drug in the body. The orally administered anxiolytic/antidepressant drug is FDA-approved for the treatment of major depressive disorder and panic disorder, with improved patient tolerability and lower patient dropout, according to the company.

NEW LABELING Revised labeling has been approved for CD (methylphenidate HCl) Extended-Release sulesstiles 20 mg, from Celltech Pharmaceuticals, Rochester, N.Y., (716) 475-9000. The recommended dose of the ADHD drug can now be sprinkled onto a small amount of soft food, such as applesauce. The company says it's the first once-daily methylphenidate product to receive this approval, malting it easier for ADHD patients who experience difficulty in swallowing to adhere to their medication regimen.


The FDA has cleared the Nupin AQ Pen for exclusive use with the Nutropin AQ Pen Cartridge, for delivering Nutropin AQ (somatropin [rDNA origin] injection), a human growth hormone. The pen, designed and manufactured for Genentech, South San Francisco, (650) 225-1000, gives patients a simple, convenient way to administer their growth hormone replacement therapy from a single prefilled 10 mg/2 ml cartridge.


Fougera, Melville, N.Y., (800) 645-9833, a division of Altana Inc., has FDA approval to market generic desonide lotion 0.05%, a topical corticosteroid. The product provides an alterna-- tive to Galderma's DesOwen, which is indicated for the relief of inflammatory and pruritic manifestation of corticosteroidresponsive dermatoses. It will be available in 59-ml and 118-ml bottles. Desonide ointment 0.05%, approved earlier, will be available in 15- and 60-gin tubes.

The FDA has given ANDA approval to KV Pharmaceutical Co., St. Louis, (800) 447-4537, for prednisolone syrup 15 mg/5 ml and 5 mg/5 ml. As a generic equivalent to Prelone, from Muro Pharmaceutical, the glucocorticoid is indicated for the management of a variety of disorders, including endocrine, rheumatic, dermatologic, allergic, ophthalmic, respiratory, hematologic, and other diseases.

Roxane Laboratories, Columbus, Ohio, (614) 2724774, is introducing two new generic products. Megestrol acetate oral suspension, 40 mg/ml, is indicated for the treatment of anorexia, cachexia, or unexplained significant weight loss in patients diagnosed with AIDS. The medication, claimed to be bioequivalent to Bristol-Myers Squibb's Megace, is packaged in 240ml bottles and comes with a calibrated dosage cup. Midazolam hydrochloride syrup 2 mg/ml offers a generic alternative to Roche Laboratories' Versed syrup. The benzodiazepine is used in pediatric patients for sedation, anxiolysis, and amnesia prior to diagnostic, therapeutic, or endoscopic procedures or before the induction of anesthesia.

Approval has been granted to Andrx Corp., Fort Lauderdale, Fla., (800) 6217143, for two strengths (10 and 20 mEq) of potassium chloride extendedrelease tablets, a generic alternative to ScheringPlough's K-Dur. The potassium supplement is used to treat low blood potassium levels, a common occurrence in people taking certain drugs to treat high blood pressure.

American Pharmaceutical Partners, Los Angeles, (800) 551-7176, has entered into an agreement with SuperGen Inc. for the sale and distribution of mitomycin. …

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