Generics

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.

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.

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.

PISCATAWAY, N.J. — The U.S. subsidiary of India-based generic drug maker Hetero Drugs has appointed Konstantin Ostaficiuk as its president, Camber said.

Ostaficiuk, who often goes by the nickname of Kon, succeeds Briggs Arrington, who has gone on to work for Hetero’s senior management team to find new opportunities for the company’s U.S. manufacturing operations. Ostaficiuk has worked in the generic drug industry for 25 years, having joined Camber in 2009 as VP sales and marketing.

PITTSBURGH — Though more than 7-in-10 drugs dispensed in the United States today are generics, and the Food and Drug Administration holds generics to the same standards as branded drugs, misgivings among the general public still exist, fed by the occasional media report of patients experiencing bad side effects after taking certain generic drugs.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.

The drug maker said its abbreviated new drug application for ranitidine syrup in the 15-mg/mL strength was approved. Ranitidine syrup is a generic version of GlaxoSmithKline’s Zantac syrup, which garnered sales of $21 million for 12 months ended in December 2010, according to IMS sales data.

Hi-Tech currently has 13 products awaiting approval at the FDA, the company said.

MORRISTOWN, N.J. — A subsidiary of Watson Pharmaceuticals has launched a treatment for herpes infections, the company said Monday.

Watson Labs launched famciclovir tablets in the 125-mg, 250-mg and 500-mg strengths. The drug is a generic version of Novartis’ Famvir and is used to treat cold sores and genital herpes in patients with and without HIV.

Famvir and generic versions had sales of about $197 million in 2010, according to IMS Health.

NEW YORK — Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.