New Product Newswire - Drugs, Indications, Formulations, Package size, Generics
From Organon Inc., West Orange, N.J., (973) 325-5353, comes a new drug delivery system, the vaginal insert NuvaRing (etonogestrel/ ethinyl estradiol vaginal ring). The small, flexible, transparent ring, which delivers 0.120mg/ 0.015 mg of the combination estrogen/ progestin per day, provides month-long contraceptive protection. First approved by the FDA in 2001, the device is now available for distribution in the United States.
An expanded indication for Nasonex (mometasone furoate monohydrate) has been granted to Schering-Plough, Kenilworth, N.J., (908) 298-4000. The nasal corticosteroid, indicated for the treatment of seasonal and perennial nasal allergy symptoms, has been cleared to treat children age two years and older. It was previously indicated for children age three and above.
A new 10/20-mg formulation has been added to the Lotrel (amlodipine/benazepril HCl) franchise, from Novartis Pharmaceuticals Corp., East Hanover, N.J., (973) 871-8300. Once-daily Lotrel combines the calcium-channel blocker amlodipine found in Pfizer's Norvasc with the ACE inhibitor of Novartis' Lotensin (benazepril HCl). Lotrel, also available in 2.5/10 mg, 5/10 mg, and 5/20 mg, is indicated for treating high blood pressure.
A new formulation of Mesnex (mesna) can now shorten the length of time chemotherapy patients are required to remain at a care center for ifosfamide infusion. Mesnex is coadministered with ifosfamide to reduce the incidence of ifosfamide-induced hemorrhagic cystitis. Mesnex is still given intravenously at the time of ifosfamide administration, but follow-up treatment can now be provided by Mesnex tablets at two and six hours following ifosfamide treatment. Bristol-Myers Squibb, maker of ifosfamide, will be copromoting Mesnex tablets, from Baxter Healthcare Corp., Deerfield, Ill., (847) 948-2000, during the initial launch period.
Atrix Laboratories, Fort Collins, Colo., (970) 482-5868, has received approval from the FDA for Eligard 22.5 mg (leuprolide acetate for injectable suspension). Approval of the three-month sustained-release product follows closely the approval of Eligard 7.5 mg 10 months earlier. Eligard is a synthetic gonadotropin-releasing hormone (GnRH) for the palliative treatment of advanced prostate cancer. The product will be distributed through Atrix's marketing partner, Sanofi-Synthelabo.
Berlex Laboratories, Wayne, N.J., (973) 694-4100, is making available a new 50-gm tube size of Finevin (azelaic acid cream) 20%. The product is indicated for the topical treatment of mild to moderate inflammatory acne vulgaris. Finevin, know as Skinoren in Europe, is distributed worldwide by Berlex's German parent company, Schering AG. The cream is categorized as a pregnancy category B, and it is not recommended for use in patients under the age of 12.
IVAX Corp., Miami, (305) 575-6000, has won generic approval for misoprostol, for prevention of nonsteroidal anti-inflammatory drug-induced gastric ulcers. The tablets, available in 100- and 200-mcg strengths, are a synthetic prostaglandin E1 analog, offering an alternative to Cytotec, from G. D. Searle.
The opioid analgesic tramadol, a generic version of Johnson & Johnson's Ultram, is now approved for Alpharma Inc., Baltimore, (410) 298-1000. The drug is indicated for the management of moderate to moderately severe pain.
Purepac Pharmaceutical, Elizabeth, N.J., (908) 527-9100, has received approval to manufacture and market tizanidine hydrochloride in 2-mg and 4-mg tablets. Tizanidine is a centrally acting alpha-2 adrenergic agonist indicated in the management of spasticity. Its approval provides a generic alternative to Elan's Zanaflex.
Nancy Jillard. New Product Newswire. Drug Topics 2002;16:48.