Regulatory and Washington

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a topical pain treatment made by Hi-Tech Pharmacal, the drug maker said Thursday.

The agency approved Hi-Tech’s sterile lidocaine jelly in the 2% strength, used for treating pain in procedures involving the urethra, painful urethritis and in endotracheal intubation.

Various versions of the drug had sales of $17 million in 2010, according to IMS Health.

PRINCETON, N.J. — Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

The company said its phase-3 trial for investigational compound ipilimumab, designed for previously untreated patients that were diagnosed with metastatic melanoma, improved overall survival. The study compared the combination of ipilimumab 10 mg/kg and chemotherapy (dacarbazine) with chemotherapy alone.

The Consumer Healthcare Products Association may not be painting pink Pepto-Bismol mustaches on a group of Hollywood celebrities and professional athletes as part of the new campaign it plans to fully unveil in June, but the goal is more or less the same as the “Got Milk?” ads.

“Got milk?” has become ubiquitous. There is 100% clarity of message. The milk mustache says it all: Milk is an essential food and an integral part of a healthy diet; it HAS TO BE in your refrigerator, on your breakfast table and in your lunch box.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for shingles and genital herpes made by Actavis, the drug maker said Wednesday.

The FDA approved Actavis’ valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths.

The drug is a generic version of GlaxoSmithKline’s Valtrex. Branded and generic forms of the drug had sales of about $1.5 billion in 2010, according to IMS Health.

LONDON — GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men's risk of developing prostate cancer.

The drug maker announced it no longer would pursue global approval for Avodart (dutasteride) and would work with regulatory agencies to remove the indication from the product’s license.

PRINCETON — Sandoz has introduced an authorized generic version of a herpes treatment made by parent company Novartis, the company said Thursday.

Sandoz announced the launch of famciclovir tablets, an authorized generic of Famvir, used to treat genital herpes and cold sores in patients with healthy immune systems, and to treat shingles and herpes simplex infections of the skin and mucosa in patients with HIV.

Authorized generics are branded drugs sold under their generic chemical names at a reduced price, often through third-party companies.

HUNTSVILLE, Ala. — The Food and Drug Administration has approved a generic drug for cardiovascular disease made by Qualitest Pharmaceuticals.

Qualitest announced Thursday the approval of toresmide tablets in the 5-mg, 10-mg, 20-mg and 100-mg strengths.

The drug is used to treat edema associated with congestive heart failure, kidney disease or hepatic disease, and also for hypertension.

BASEL, Switzerland — The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.