Content about Drug safety

SILVER SPRING, Md. — Globalization has led to a rapid increase in the drugs and foods arriving on U.S. shores from abroad, a trend that has prompted U.S. regulators to transform their approach.

The Food and Drug Administration released a report Monday detailing its strategies for what it called transforming from a domestic to a global public health agency.

HAYWARD, Calif. — The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

Impax Pharmaceuticals, the branded products division of Impax Labs, said it filed its NDA for the investigational drug IPX066, an extended-release capsule formulation of carbidopa-levodopa, for review in December 2011. IPX066 has been licensed to GlaxoSmithKline for countries outside the United States and Taiwan for development and marketing.

NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review by the European Medicines Agency.

WHAT IT MEANS AND WHY IT'S IMPORTANT — If the ultimate goal of the Affordable Care Act is to save money and expand patient care, then making patients visit their physicians and get prescriptions just to get reimbursed for over-the-counter medications — which wastes money, as well as the time of physicians, a precious commodity when the country is set to have a shortage of them — makes no sense.

SUPPLIER NEWS — The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths. Promethazine hydrochloride tablets, which are manufactured by several companies, had sales of about $42 million during the 12-month period ended in June, according to IMS Health.


SAN DIEGO — NexMed USA on Thursday received clearance from the Food and Drug Administration to market the company's first over-the-counter antifungal drug, Tolnaftate-D.

NexMed USA's Tolnaftate-D incorporates NexACT, a proprietary drug delivery technology that transiently loosens the tight junction between the cells of the sealed skin to allow more permeation.

WOODCLIFF LAKE, N.J. — Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.

Par said it will acquire Edict Pharmaceuticals for up to $37.6 million in cash and Par's repayment of certain additional pre-close indebtedness. Par noted the acquisition is subject to customary conditions and approvals; the drug maker expects to complete the transaction by the end of the year.

HAYWARD, Calif. — The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

Impax Pharmaceuticals, as the division is known, said it filed an investigational new drug application with the Food and Drug Administration for IPX159 and started a phase-1 study.

ALLEGAN, Mich. — Perrigo on Tuesday announced that the Detroit office of the Food and Drug Administration has concluded its re-inspection of Perrigo's Allegan facility.

The FDA has informed Perrigo that, effective immediately, Perrigo has an acceptable regulatory status, such that any pending export license and abbreviated new drug applications from this facility will once again be eligible for review and approval.

PALM BEACH GARDENS, Fla. Parents’ confusion over correctly administering over-the-counter medication to their children appears to be shared worldwide, according to a new study presented this week in Lisbon, Portugal, by Rebekah Moles from the University of Sydney.

SAN RAMON, Calif. The Special Interest Group for IIAS Standards announced Wednesday that the group is making significant changes to its Eligible Products List — a list of over-the-counter products eligible for reimbursement under flexible spending accounts — in response to IRS guidance issued earlier this month.