Content about New Drugs & OTCs

GOLDEN, Colo. — Supplement maker iSatori has launched a new weight-loss supplement product, the company said.

BioGenetic Labs, a division of the company, announced Tuesday the pending launch of Belly-Off, a combination of conjugated linoleic acid, guarana, yerba mate and damiana designed to help users reduce belly fat. The company plans to start shipping the product this month and make it available at retailers nationwide in January 2013.

LONDON — The Food and Drug Administration has approved a new biotech drug from GlaxoSmithKline for anthrax, the drug maker said.

GSK announced the approval of raxibacumab for adults and children who have inhaled Bacillus anthracis. The drug is designed for combination with antibiotics and for preventing inhalational anthrax when alternative therapies aren't available. The drug is the result of a project that Human Genome Sciences, now owned by GSK, began working on in 2001 in response to terrorist anthrax attacks in the United States.

JACKSON, Wis. — Wisconsin Pharmacal, in an exclusive licensing partnership with the Coleman Co., has introduced unique, individualized first aid tins. Each tin contains commonly used first aid components including bandages, antibiotic ointment, antiseptic wipes and more, and comes packaged in a nostalgic, brushed-metal tin case with an embossed first aid cross adorning the lid.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced the approval of Novartis' Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older.

NEWBURY, Ohio — Hebron USA on Monday announced the launch of the Florax DS, a line of ready-to-drink probiotics that doesn't require refrigeration. 

Florax DS products are formulated with a proprietary strain of the probiotic yeast called Saccharomyces Cerevisiae Cepa Fr 1972, also known as a nutritional or brewers' yeast.  

The Florax DS RTDs will be available in two flavors — original and raspberry — through Drugstore.com, Meijer, Discount Drug Mart and Rainforestsremedies.com.

CHICAGO — Nurish Brands on Thursday launched Feel Natural Energy, a new energy drink available in Rexam 10.5-oz. Sleek cans.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

Mylan announced the FDA approval of sildenafil citrate tablets in the 20-mg strength, a generic version of Pfizer's Revatio. The drug is used to treat adults with PAH to improve exercise ability and delay clinical worsening of the condition.

Revatio had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for pulmonary arterial hypertension made by Watson Pharmaceuticals, the drug maker said Monday.

Watson said the FDA approved its sildenafil tablets in the 20 mg strength through a subsidiary. Watson said it would launch the drug "in the near future."

The drug is a generic version of Pfizer's Revatio tablets, which had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

NEWPORT BEACH, Calif. — Absorption Pharmaceuticals recently launched Promescent, an over-the-counter lidocaine-based spray indicated for premature ejaculation. The product is presently available at www.Promescent.com, through doctors’ offices and independent pharmacies. 

 Created by a urologist, the spray is designed to absorb below the surface of the skin where nerve endings that control ejaculation are located.

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.

J&J subsidiary Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) for treating deep-vein thrombosis and pulmonary embolism and to reduce the risk of recurrence of the clotting conditions after initial treatment.

The company said Xarelto was the first oral anticoagulant approved to treat DVT and PE without the need for injections or routine blood-monitoring.