Generics

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.

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.

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.

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.

NEW YORK — While several drugs to treat Type 2 diabetes are on the market, researchers have found that the best first-line option is metformin.

Led by Wendy Bennett, an assistant professor of medicine at Johns Hopkins University School of Medicine in Baltimore, researchers reviewed 140 trials and 26 observational studies of head-to-head comparisons of monotherapy or combination therapy that reported intermediate or long-term clinical outcomes or harms of six oral diabetes medications.

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

Watson said the U.S. District Court for the District of Delaware ruled that Watson’s generic version of Cephalon’s Fentora (fentanyl buccal tablets) does not infringe on two patents that were set to expire in March 2019, according to Food and Drug Administration records.

WASHINGTON — Five senators have issued a letter to Food and Drug Administration commissioner Margaret Hamburg to expand Americans' access to affordable medications by avoiding the delay of generic drug approvals.