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Peggy Peck
Articles
FDA Says No to New Cox-2 Inhibitor
April 27, 2007
WHITEHOUSE STATION, N.J., April 27 -- Merck said today that the FDA has rejected the investigational Cox-2 inhibitor etoricoxib (Arcoxia) for marketing.
Wiring Problem Prompts Recall of 300,000 CPAP Devices
April 26, 2007
ROCKVILLE, Md. -- Some 300,000 home continuous positive airway pressure devices have been recalled by ResMed after short circuits from faulty wiring in electrical plugs, reported the FDA.
FDA Okays Generic Zolpidem
April 25, 2007
ROCKVILLE, Md. -- The FDA has approved the first generic versions of zolpidem tartrate, marketed for years as Ambien, for short-term treatment of insomnia.
Pay-for-Performance Plans a Major Component of Medicaid
April 13, 2007
NEW YORK -- More than half the states have tied payment to performance for Medicaid services for some of their health care programs, according to a survey just published.
Critics of FDA User Fees Shoot for Reform by Congress
April 13, 2007
BOSTON -- Hefty user fees from pharmaceutical companies account for some 40% of the FDA?s budget for new-drug reviews, but this scheme that spurs speedier approvals worries safety watchdogs.
FDA Advisers Give Overwhelming Rejection to Etoricoxib (Arcoxia)
April 12, 2007
GAITHERSBURG, Md. -- By a vote 20 to one, FDA advisers recommended today against approval of Merck's Cox-2 inhibitor etoricoxib (Arcoxia), declaring that the cardiovascular risks of the drug outweigh its benefits for easing arthritis pain.
FDA Alerts Pharmacists About Mislabeling of HIV Drugs
April 11, 2007
ROCKVILLE, Md. -- The FDA and GlaxoSmithKline have warned pharmacies about a drug-tampering incident that resulted in misbranding of two drugs used to treat HIV.
Glass Fragments Force Recall of Liquid Ringworm Medication
April 11, 2007
ROCKVILLE, Md. -- The FDA said two reports of glass fragments in a liquid antifungal triggered a nationwide recall of griseofulvin (Grifulvin V), microsize 125 mg/5mL.
Shortened Battery Life Forces Recall of 73,000 Implantable Defibrillators
April 11, 2007
ROCKVILLE, Md. -- Guidant has recalled approximately 73,000 implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) because of a defect that shortened battery life, the FDA reported.
FDA Okays Sitagliptin (Januvia)-Metformin Combo Tablet
April 03, 2007
ROCKVILLE, Md. -- The FDA has approved the first type 2 diabetes treatment that includes a dipeptidyl peptidase-4 (DPP-4) inhibitor with metformin in a single tablet.