New product newswire

RX

NEW DRUGS

To help Type 2 diabetes patients better manage their blood glucose levels, Takeda Pharmaceuticals, Lincolnshire, Ill., (847) 383-3000, now has a new product that combines two diabetes medications in a single tablet. ACTOplus met (pioglitazone HCl and metformin HCl) combines the already approved ACTOS, which targets insulin resistance, and metformin, which reduces the amount of glucose produced by the liver. The new combination will be available in two pioglitazone/metformin doses: 15 mg/500 mg and 15 mg/850 mg, as once-a-day therapy.

NEW INDICATIONS

OSI Pharmaceuticals, Melville, N.Y., (631) 962-2000, and Genentech, South San Francisco, (650) 225-1000, have been granted FDA approval to market Tarceva (erlotinib) in combination with Gemzar (gemcitabine, Eli Lilly) for first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer. Tarceva, a once-daily oral tablet, was already approved for treatment of non-small cell lung cancer that had progressed after one or more courses of chemotherapy.

Merck & Co., Whitehouse Station, N.J., (908) 423-1000, has received FDA approval for a new indication for Invanz (ertapenem). The once-daily injectable antibiotic can now be used for the treatment of moderate to severe complicated foot infections due to indicated pathogens in diabetic patients without osteomyelitis.

NEW FORMULATIONS

The FDA has given Fort Worth-based Galderma Laboratories, (817) 961-5000, marketing approval for Clobex (clobetasol propionate) Spray, 0.05%. The super-high-potency corticosteroid non-aerosol spray, developed by Dow Pharmaceutical Sciences, is indicated for twice-daily treatment of moderate to severe plaque psoriasis. There were earlier approvals for Clobex Lotion and Clobex Shampoo.

Abbott Laboratories, Abbott Park, Ill., (800) 255-5162, has a new tablet formulation of its HIV protease inhibitor Kaletra (200 mg lopinavir/50 mg ritonavir) that provides similar drug levels in the blood relative to Kaletra capsules. Patients can now take fewer pills per dose: four tablets per day versus the prior regimen of six capsules per day. The drug can be taken with or without food, and the tablets require no refrigeration. The capsules are being phased out over the forthcoming months, with the new tablets replacing the capsules entirely.

NEW LABELING

Enzon Pharmaceuticals, Bridgewater, N.J., (908) 541-8600, has received approval for a new route of administration for its oncology drug Oncaspar (pegaspargase), a treatment for pediatric lymphoblastic leukemia. Intravenous administration is a new option that stands to reduce the number of intramuscular injections required for treatment.

A new dosing regimen has been approved for lipid-lowering Antara (fenofibrate) capsules. Antara is a product of Reliant Pharmaceuticals, Liberty Corner, N.J., (908) 580-1200. Patients can now take the 130-mg dose either with or without food. The drug is indicated as adjunctive therapy to diet to reduce elevated LDL-C, total-C, triglycerides, and ApoB and to increase HDL-C in adults with primary hypercholesterolemia or mixed dyslipidemia and adult patients with hypertriglyceridemia. It is also available in a 43-mg strength.

NEW GENERICS

Sicor Pharmaceutical Sales, Irvine, Calif., (800) 729-9991, a subsidiary of TEVA Pharmaceuticals USA, has introduced octreotide acetate injection in 50 mcg/mL, 100 mcg/mL, and 500 mcg/mL concentrations. The drug is indicated to achieve normalization of growth hormone and IGF-I levels in acromegaly patients who have shown inadequate response to surgical resection, pituitary irradiation, and bromocriptine mesylate. The product provides a generic alternative to Novartis' Sandostatin.

Approval for Fluocinolone Acetonide Oil 0.01% ear drops was granted to Hill Dermaceuticals, Sanford, Fla., (800) 344-570. The topical synthetic steroid, an anti-inflammatory and antipruritic agent, is indicated for treating chronic eczematous external otitis.