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Andrx Pharmaceuticals has filed a citizen’s petition with the FDA requesting that the agency seek the advice of the Federal Trade Commission (FTC) and the Justice Department on the contentious issue of authorized generics.
Noven Pharmaceuticals claimed in a recent filing with the FDA that its efforts to bring a generic version of Johnson & Johnson's (J&J) Duragesic transdermal pain patch to market are being deliberately blocked by a “suspicious” string of citizen petitions.
Despite comments in a recent docket submission to the FDA that appear to indicate some softening on the topic, a representative of the trade group Biotechnology Industry Organization (BIO) says the organization is not relaxing its position on an abbreviated approval process for generic biologics.
The increased use of generic drugs will provide more significant cost savings to consumers than practices such as drug importation and price controls, a pair of reports issued by the federal government in late December 2004 indicate.
The FDA recently issued a warning letter to Charlotte, N.C.-based Alveolus stating that the company violated current good manufacturing practice (cGMP) requirements by removing its Tracheal Bronchial Stent Technology (TB-STS) from the market without proper notification.
The U.S. Drug Enforcement Administration (DEA) has established an international toll-free hotline to receive anonymous reports about illegal sales, diversion or abuse of prescription drugs.
Even though the company already has been licensed by brand drugmaker Cephalon to manufacture and market the product, generic firm Barr Laboratories has filed an abbreviated new drug application (ANDA) with a paragraph IV certification for a generic version of Actiq.
Alleging the company illegally imported drugs into the U.S., the FDA has filed a civil lawsuit against Canada Care Drugs, Claire Ruggiero and Christine Ruggiero.