New Product Newswire

NEW PRODUCT NEWSWIRE

Rx

NEW INDICATIONS

Abbott Laboratories' TriCor (fenofibrate capsules, micronized), which is already approved to reduce total cholesterol, LDL cholesterol, and triglyceride levels, is now cleared for a new indication: increasing HDL cholesterol levels in patients with high LDL cholesterol with or without high triglycerides. The Abbott Park, Ill., firm said that TriCor is the first drug in the fibrate class of lipid-regulating agents that can make this claim. Separately, Abbott said that it is launching TriCor tablets to replace the capsules. The tablets offer increased bioavailability over capsules, allowing patients to get equivalent concentrations of the drug in their bloodstream at a lower dose. TriCor tablets, in both 54-mg and 160-mg strengths, are equivalent to 67-mg and 200-mg capsules, respectively, when taken with food. Pharmacies should use up their supply of capsules, then ask physicians for authorization to switch scripts from capsules to tablets. For more information, call the company at (800) 255-5162.

Tazorac Cream (tazarotene cream 0.1%), from Allergan Inc., which was formerly approved for treating plaque psoriasis, is now approved for use in relieving acne vulgaris as well. The Irvine, Calif., firm also markets Tazorac Gel, which is indicated for the management of both psoriasis and acne. Allergan's customer service number is (800) 377-7790.

The FDA has now approved Foradil (formoterol fumarate inhalation powder) Aerolizer, for long-term administration in the maintenance treatment of brochoconstriction in patients suffering from chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The medication is indicated for twice-daily (morning and evening) use. In February of 2001, Foradil, a long-acting beta₂ agonist, was initially approved for use in the treatment of asth-ma and prevention of bronchospasm in patients five years of age and older with reversible obstructive airway disease. Foradil is manufactured by Novartis Pharmaceuticals Corp., East Hanover, N.J., (973) 781-8300.

NEW FORMULATIONS

Adderall, available from Shire Pharmaceuticals Group plc, now comes in a long-acting, once-daily formulation. Under the name of Adderall XR (mixed salts of a single-entity amphetamine product), the attention deficit/ hyperactivity disorder medication should be taken in the morning, and it lasts the whole day. Shire Pharmaceuticals is headquartered in Florence, Ky., and the company can be reached at (800) 536-7878.

Braintree Laboratories, which makes PhosLo Tablets, has unfurled PhosLo GelCaps (calcium acetate). The Braintree, Mass., company said that the product has been formulated to control hyperphosphatemia in patients with end-stage renal disease. For further information, the company can be reached at (781) 843-2202.

Abbott Laboratories' Zemplar (paricalcitol injection), which already is available in 5-mcg and 10-mcg vials, will debut in a 2 mcg/ml concentration this December. Abbott said it's launching this smaller dosage option since many physicians are requesting it. Zemplar, a vitamin D analog, is designed to treat secondary hyperparathyroidism associated with chronic kidney failure.

Odyssey Pharmaceuticals will trot out Custodiol HTK Solution before the end of the year. The liquid is used for the perfusion and flushing of donor kidneys. Odyssey, a part of Sidmak Laboratories, which markets generic cyclosporine, said the product is expected to gain approval for use with other organ transplants (liver and heart) in early 2002. For more information, call Odyssey at (877) 427-9068.

DRUG RERELEASE

About a half-year after the company voluntarily recalled some batches of its Crinone progesterone vaginal gel, 4% and 8% strengths, Serono Inc., Norwell, Mass., (800) 283-8088, is rereleasing the product. The 4% strength is indicated for women with secondary amenorrhea; the 8% strength is indicated for use in assisted reproductive technologies as treatment of progesterone insufficiency due to reduced or absent ovarian function. Although Crinone did not pose a health risk, Serono volluntarily recalled the vaginel gel this past spring after the product's manufacturer, Columbia Laboratories, found that the viscosity of the product did not always remain stable, causing it to be partially expelled when the applicator was opened prior to administration. According to the manufacturer, investigations of the drug application problem have confirmed that there is no safety risk for patients and that the active ingredient—progesterone—is still effective.

NEW GENERICS

A new generic medication is available from American Regent Laboratories, Shirley, N.Y. The company is now offering levocarnitine injection, USP, 200 mg/ml, indicated for the acute and chronic treatment of patients with an inborn error of metabolism that results in secondary car-nitine deficiency. Levocarnitine injection is the generic equivalent of Sigma Tau Pharmaceuticals' Carnitor, a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane. The new generic is available in a 5-ml single-dose vial. The company can be reached at (800) 645-1706.

South Plainfield, N.J.-based Able Laboratories, (908) 754-2253, received approval from the FDA for its Abbreviated New Drug Application (ANDA) for lithium carbonate capsules, USP, in 300-mg strength. According to the company, the anti-mania drug is bioequivalent and therapeutically equivalent to Eskalith capsules, from GlaxoSmithKline. Lithium carbonate is used in treating manic episodes of bipolar disorder.

TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA, is introducing both flutamide capsules, USP 125 mg and enalapril maleate and hydrochlorothiazide tablets, USP. The flutamide capsules are the generic equivalent of Schering Corp.'s Eulexin capsules, for use in combination with LHRH agonists for the management of locally confined Stage B₂-C and D₂ metastatic carcinoma of the prostate. They will be available in 180- and 500-count bottles. Enalapril maleate and hydrochlorothiazide tablets, indicated for the treatment of hypertension, are bioequivalent to Merck & Co.'s Vaseretic. They will be available in the same strengths as the brand: 10 mg/25 mg (bottles of 100 and 1,000) and 5 mg/12.5 mg (bottles of 100).

American Pharmaceutical Partners (APP), Los Angeles, (800) 551-7176, has received FDA approval for two new generic drugs and tentative FDA approval for two others. The FDA has approved thiotepa for injection, USP, a generic alternative to Immunex Corp.'s Thioplex, indicated for palliation in a variety of neoplastic diseases. It will be available in a 2-ml vial in late 2001. The FDA has also approved propranolol injection, USP, a beta-blocker offered as an alternative to Wyeth-Ayerst's Inderal, approved for various cardiac indications, including hypertension, cardiac arrhythmia, and myocardial infarction. APP has received tentative FDA approval for the antiarrhythmic agent amiodarone HCl injection, a generic alter-native to Cordarone, from Wyeth-Ayerst. Amiodarone HCl injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. In addition, APP has received tentative FDA approval for the bisphosphonate pamidronate for injection, USP. The product, available in 30-mg and 90-mg vials, is the generic equivalent of Novartis' Aredia, indicated for treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.

OTC

Bayer Consumer Care Division, Morristown, N.J., (973) 254-5000, is introducing chewable One-A-Day Kids Scooby-Doo Multi-vitamins in orange, grape, and cherry flavors. The new product combines One-A-Day vitamins with chewable tablets in the shape of Scooby-Doo, his dog tag, or a bone-shaped Scooby snack. Scooby-Doo Complete provides 19 essential vitamins and minerals, including vitamin C, iron, and calcium. Scooby-Doo Plus Calcium has 10 essential vitamins plus as much calcium as 5 oz. of milk.

Pharmacia Corp., Peapack, N.J., (908) 901-8000, is now offering two new over-the-counter medications. Pediacare Cold & Al-lergy (pseudoephedrine hydrochloride and chlorpheniramine) has been formulated for children ages six to 12 and can be used to treat sneezing; stuffy, runny nose; and itchy, watery eyes. The liquid formulation, which is available in bubblegum flavor, contains a decongestant and an antihistamine to help prevent and relieve cold and allergy symptoms. Pediacare Long-Acting Cough Plus Cold, a liquid cold medicine for children ages two to 12, contains decongestant and anticough ingredients to relieve stuffy noses and coughing caused by the common cold.

Combining over-the-counter medicines for managing pain and natural supplements designed to repair worn cartilage, Inholtra Joint Pain is now available from Omni Nutraceuticals, Los Angeles, (800) 841-8448. The patented formula contains aspirin and acetaminophen to help reduce arthritis pain, and glucosamine and chondroitin to help rejuvenate and strengthen cartilage and connective tissues and draw fluids into the protective cartilage area surrounding bones and joints.

Barbara Klink. New Product Newswire.

Drug Topics

2001;21:49.