New Product Newswire

January 7, 2002

New Products

 

NEW PRODUCT NEWSWIRE

Rx

NEW DRUGS

A new vitamin supplement has now been added to the line of prenatal vitamins from Integrity Pharmaceutical Corp., Fishers, Ind., (800) 823-6878. StuartNatal Plus 3 is a multivitamin/ multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy—and in the postnatal period for both lactating and nonlactating mothers. In addition, it can help improve the nutritional status of women prior to conception. According to the company, the product meets all US Pharmacopeia standards for quality, potency, purity, and dissolution for all active ingredients, including folic acid.

A new prescription-only lotion for treating mild to moderately dry skin conditions is now available from Doak Dermatologics, Fairfield, N.J., (800) 929-9300, a subsidiary of Bradley Pharmaceuticals. Carmol 40 (40% urea) Lotion is the latest addition to the Carmol line of urea-based skin care products. The fragrance-free formulation treats such skin conditions as psoriasis, xerosis, and ichthyosis.

NEW FORMULATION

The FDA has granted Bayer, West Haven, Conn., (800) 468-0894, approval of its intravenous formulation of Avelox (moxifloxacin hydrochloride in sodium chloride for injection) for the treatment in adults of community-acquired pneumonia, acute bacterial sinusitis, acute bacterial exacerbations of chronic bronchitis, and uncomplicated skin and skin structure infections. The tablet form of Avelox was approved in December 1999 for treating common adult respiratory tract infections.

King Pharmaceuticals, Bristol, Tenn., received FDA approval for Tigan (trimethobenzamide hydrochloride) 300-mg capsules. The product is indicated for treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. Tigan will be marketed through Monarch Pharmaceuticals. For ordering information, call (800) 776-3637 or (888) 358-6436.

Endo Pharmaceuticals Holdings, Chadds Ford, Pa., (800) 462-3636, has received FDA approval to market reformulated Percocet 7.5/325 mg and Percocet 10/325 mg oxycodone/acetaminophen tablets. Percocet is indicated for the treatment of moderate to moderately severe pain. The reformulated products have a reduced acetaminophen content and are designed to permit the synergistic effect of the two analgesics while lowering the risk of excessive acetaminophen exposure.

NEW GENERICS

Available also from Endo Generic Products, Chadds Ford, Pa., are morphine sulfate extended-release tablets, 200 mg. The new offering is an AB-rated generic alternative to MS Contin (Purdue Frederick) and is indicated for relief of pain in opioid-tolerant patients.

United Research Laboratories/Mutual Pharmaceutical Co., Philadelphia, (800) 523-3684, has received approval of its Abbreviated New Drug Application for sotalol HCl tablets USP, 80 mg, 120 mg, 160 mg, and 240 mg. Sotalol HCl tablets are the AB-rated generic equivalent of Betapace, from Berlex Laboratories. They are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. The drug is available under the United Research Laboratories label.

Daunorubicin, an anticancer drug, is being introduced by SuperGen Inc., Dublin, Calif., (800) 353-1075. Daunorubicin in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) in adults and for remission induction in acute lymphocytic leukemia in adults and children.

Two new generic oral contraceptives are in the works from Barr Laboratories, Pomona, N.Y., (800) BARRLAB. Barr has received FDA approval of its application to manufacture and market a generic version of Wyeth-Ayerst's Lo/ Ovral Tablets. The company will market the product, which was acquired as part of the merger with Duramed Pharmaceuticals, under the Cryselle trade name. The contraceptive is a regimen of oral contraceptive pills that contain 0.3 mg of norgestrel and 0.03 mg of ethinyl estradiol. It is indicated for the prevention of pregnancy. Barr plans to begin shipping Cryselle in the first quarter of 2002 ... In addition, Barr has received tentative approval of a generic version of Organon Inc.'s Mircette. Barr was granted summary judgment in its challenge of the patents protecting Mircette, and, pending FDA approval, the product may begin shipping this month. The generic version will be a 28-day tablet regimen containing a combination of desogestrel/ ethinyl estradiol and ethinyl estradiol. It is indicated for the prevention of pregnancy.

Barr has also received FDA approval for etham-butol hydrochloride tablets, 400 mg, USP. The approval provides a generic equivalent of Dura Phar-maceuticals' Myambutol tablets, indicated for the treatment of pulmonary tuberculosis. The drug should be used in conjunction with at least one other antituberculosis drug.

Lannett Co., Philadelphia, (215) 333-9000, is now offering butalbital, aspirin, caffeine, and codeine phosphate capsules. The new product offers a generic version of Fiorinal with Codeine Phosphate capsules, from Novartis Pharmaceuticals Corp. It is indicated for the treatment of tension headaches.

Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-5615, a wholly owned subsidiary of Ranbaxy Laboratories Ltd., received FDA approval for acetaminophen and codeine phosphate tablets USP, 300 mg/30 mg and 300 mg/60 mg. The products are AA rated and therapeutically equivalent to Tylenol with Codeine tablets USP, No. 3 and No. 4, respectively. Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. The final dosage form will be manufactured and packaged at Core Pharma LLC, Middlesex, N.J., and marketed through the Ranbaxy's sales and marketing organization.

Ranbaxy has also received tentative approval from the FDA for lisinopril tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg, and 40 mg. Based on kinetic studies, the generic has been determined to be bioequivalent and therapeutically equivalent to Zestril tablets, from AstraZeneca Pharmaceuticals. Lisinopril is indicated, either alone as initial therapy or concomitantly with other classes of antihypertensive agents, for the treatment of high blood pressure. It is indicated also as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis as well as for improving survival in hemodynamically stable patients within 24 hours of acute myocardial infarction.

The FDA has approved Abbreviated New Drug Applications for 10-mg, 20-mg, and 40-mg strengths of Andrx Corp.'s omeprazole delayed-release capsules. The new product is a generic version of AstraZeneca's Prilosec, used to treat duodenal and gastric ulcers and gastro-esophageal reflux disease (GERD). It is also indicated for maintenance of healing of erosive esophagitis and pathological hypersecretory conditions. Andrx is a Fort Lauderdale, Fla.-based company, (954) 584-0300.

Bedford Laboratories, a division of Ben Venue Laboratories, Bedford, Ohio, (800) 562-4797, has received FDA approval—and American Pharmaceutical Partners, Los Angeles, (310) 470-4222, and Sicor Inc., Irvine, Calif., (949) 455-4879, tentative approval —for pamidronate disodium for injection, 30 mg and 90 mg. This generic version of Aredia (Novartis Pharmaceuticals), a bone-resorption inhibitor, is indicated for the treatment of hypercalcemia associated with malignancy, for Paget's disease, and for osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma.

A new branded generic, bioequivalent to Parke-Davis' Dilantin Kapseals, is being manufactured by Mylan Laboratories, Pittsburgh, (412) 232-0100. In early December, the FDA approved Mylan's anticonvulsant Phenytek extended phenytoin sodium capsules, in 200-mg and 300-mg strengths. Mylan will market the new product, which is used to treat seizure disorders, through its subsidiary, Bertek Pharmaceuticals. The new strengths allow for once-daily dosing, which may help improve compliance.

The FDA has also approved an Abbreviated New Drug Application from Mylan Laboratories for diclofenac sodium extended-release tablets in 100-mg strength. The newly approved non-steroidal anti-inflammatory drug provides a generic alternative to Novartis Pharmaceuticals' Voltaren-XR, indicated for chronic therapy for osteoarthritis and rheumatoid arthritis.

OTC

A new topical analgesic rub specially formulated for use before, during, and after exercise is now available from Smart Science Laboratories, Odessa, Fla., (727) 375-5911, and World Triathlon Corp., Tarpon Springs, Fla., (727) 942-4767. JointFlex Ironman Sports Pain Relief Gel is designed to help reduce the aches and pains of muscles and joints associated with exercise and sports activity. It contains the active ingredients glucosamine, chondroitin sulfate, and vitamin E.

 

Barbara Klink. New Product Newswire. Drug Topics 2002;1:55.