Generics

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.

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 — 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.

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.

WASHINGTON — The generic drug industry’s main lobby in Washington is hoping to head off cuts to the Food and Drug Administration’s Office of Generic Drugs, which it said could have a “devastating impact” on those who rely on generics.

Republicans in Congress have sought to reduce government spending by making large cuts to various domestic programs and agencies, including the FDA, which critics of the plan said could jeopardize food and drug safety.

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.