Generic Drugs Require Labeling Revisions

Generic Drugs | maher law firm | frank eidson

The consumer rights group “Public Citizen”, claims there are over 433 generic drugs for which no brand-name drug remains on the market today. On Monday, the U.S. Supreme Court blocked design defect lawsuits against generic drug makers causing tremendous pressure on the FDA (Food and Drug Administration). Earlier this year, the FDA considered allowing generic [...]

Lack of regulations allow for counterfeit medications to gain global growth

Ranbaxy

Regulators have few ways to prevent fake medicines from reaching patients. Reuters (3/12, Berkrot) Lack of regulations make it hard to stop fake medications from getting to patients, and laws seeking to help may be years from enacted. Criminal and terrorist organizations are lured to counterfeit drug trade due to smaller penalties than illegal drug running. [...]

FDA Intends To Cut Generic Drug Application Review To Ten Months

Maher Law Firm / www.maherlawfirm.com /

  CNBC (2/25) reported that in a television interview, “FDA’s Margaret Hamburg” addressed the “backlog of generic drug applications at the Food & Drug Administration.” She said, “We frankly are taking too long to review important applications, and we want to help get those products out.” Hamburg aims “to bring the median review time of generic [...]

Prescription Patents Expiring Soon

This fall, prescriptions may start getting cheaper. Patents on some expensive and most prescribed drugs will begin to expire, opening the door for generic equivalents. Most notably, Lipitor, a widely used cholesterol drug made by Pfizer, will lose its patent protection November 2011. Lipitor is the “top-selling drug of all time, generating more than $9 [...]