Generics

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.

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.

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.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal has acquired the rights to a drug for mouth infections, the company said Monday.

Hi-Tech said it acquired nystatin oral suspension from Bausch & Lomb for an undisclosed sum. The drug is used to treat candidiasis, a fungal infection, in the mouth.

The market for the drug is $23 million, 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.

NEW YORK — Drug makers Gilead Sciences and Roche are suing Indian drug maker Natco Pharma concerning a generic version of an influenza treatment, according to published reports.

Bloomberg reported that Gilead and Roche were accusing Natco of patent infringement due to its efforts to gain approval from the Food and Drug Administration for a generic version of Tamiflu (oseltamivir phosphate). Natco became the first company to file for approval of a generic version in February.

ALEXANDRIA, Va. — Commenting on a counterfeit pharmaceutical inter-agency working group report, the National Association of Chain Drug Stores stressed that it shares the goal of improving the public awareness of the risks posed from counterfeit drugs and unlawful online drug sellers, but expressed concern over the report's proposal to mandate a "track-and-trace" system in the United States, given the high cost it could pose for pharmacies.