Content about New Drugs & OTCs

SILVER SPRING, Md. — The Food and Drug Administration has approved a new antiretroviral treatment for HIV made by Johnson & Johnson, the agency said Friday.

The FDA approved J&J subsidiary Tibotec Therapeutics’ Edurant (rilpivirine) as a treatment for use in combination with other HIV drugs in adults who have not been treated before.

DUBLIN — Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

PHOENIX — Arizona Sunwash has announced the launch of Solise, which it is positioning as the world's first body wash and hand wash that combines cleansing with long-lasting UVA/UVB SPF 15 sunscreen.

"Our unique formula employs natural soy emollients to bind the sunscreen with the body's natural oils. You simply lather, rinse and towel-dry as usual for full SPF 15 protection. Solise leaves your skin soft and smooth without the greasy residue typical of most sunscreens," said Michael Doyle, partner of Arizona Sunwash and creator of Solise's emulsion formula.

ALLEGAN, Mich. — Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

Zantac 150 has annual sales of approximately $110 million, as measured by SymphonyIRI Group, Perrigo reported.

PITTSBURGH — Mylan has launched a generic drug for treating post-operative inflammation in patients who have undergone cataract extraction, the company said Monday.

Mylan announced the launch of bromfenac ophthalmic solution in the 0.09% strength, for twice-daily administration, under a development and supply agreement with Coastal Pharmaceuticals.

PITTSBURGH — Generic drug maker Mylan has launched a version of a drug used to treat schizophrenia, the company said Friday.

Mylan announced the launch of risperidone orally disintegrating tablets in the 0.5-mg, 1-mg, 2-mg, 3-mg and 4-mg strengths.

The drug is a generic version of Johnson & Johnson’s Risperdal M-Tab. Various versions of risperidone orally disintegrating tablets had sales of about $61 million in 2010, according to IMS Health.

AUSTIN, Texas — In honor of Skin Cancer Awareness Month, Thinksport and Livestrong have announced that Thinksport Livestrong sunscreen now is available online and in stores just in time for summer.

Online retailers carrying the sunscreen include Drugstore.com, CVS.com, Thinksport.co, Amazon.com and REI.com. The sunscreen also is available at most Golfsmith and Whole Foods Market stores nationwide.

SWIFTWATER, Pa. — Sanofi’s vaccines division has won Food and Drug Administration approval for a vaccine designed for injection into the skin, the company said Tuesday.

Sanofi Pasteur announced the FDA approval of Fluzone Intradermal (influenza virus vaccine), which injects the vaccine into the skin via a short, fine needle, also known as a microinjection.

NEW YORK — The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

Reuters quoted FDA Center for Drug Evaluation and Research director Janet Woodcock as saying the number of drugs approved gradually could increase, already having reached a “nadir.” The report noted that 12 drugs had won approval this year so far, and Woodcock speculated that the agency would approve more than the 21 it approved last year.

MADISON, Wis. — The Food and Drug Administration has granted orphan drug designation to a treatment made by Mithridion for a rare neurological disorder, Mithridion said Monday.

WASHINGTON — The Consumer Healthcare Products Association on Wednesday announced plans to convert liquid pediatric acetaminophen products to just one concentration.

This voluntary change means the current children’s strength of liquid acetaminophen (160 mg/5 mL) will become the only liquid concentration available for all children younger than 12 years, and the current concentrated infant drops no longer will be sold.

KENNEBUNK, Maine — Tom's of Maine, a maker of natural personal care products, has announced the launch of its new natural whitening toothpaste Simply White, and a partnership with Sheryl Crow's "100 Miles From Memphis" concert that kicks off on May 7.

The project involves greening the concert tour, beautification events in key markets, a live chat with Crow on May 19 and an exclusive free song download via the Tom's of Maine Facebook page, while supplies last.