Solvay Pharmaceuticals and CV Therapeutics have announced that the U.S. Food and Drug Administ
EntreMed a clinical-stage pharmaceutical company developing therapeutics primarily for the treatment of cancer and inflammatory diseases, has announced the presentation of positive preclinical result
The Pharmacy Care Alliance today announced that it received approval from Medicare to begin education, outreach and enrollment activities for its Medicare-approved drug discount card on May 3. The Centers for Medicare an
Approval is being sought in the U.S. and Europe, by Swiss drug maker Novartis, for its breast-cancer drug Femara to be used immediately after surger
Novogen has announced the results of a Phase II clinical trial of its investigational wound healing compound, Glucoprime, in venous stasis ulcers. The trial was conducted in Australia by Novog
ID Biomedical Corporation announced today it has been advised by the United States Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) that the Company's Influenza Viru
The U.S. Food and Drug Administration (FDA) advisory panel has declared that three asthma drugs are safe enough to stay on the market, after concerns that in rare cases they raise the risk of severe asthm
Doctors are beginning the first test in the United States of a vaccine designed to protect people against one form of bird flu should an outbreak of the virus occur in humans. While the vaccine under study is not designed to protect against the precise
India's Ranbaxy Laboratories has announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Zidovudine Tablets USP, 300 mg.
Bioniche Life Sciences has announced that its Pharma Division has launched Sotradecol(R) Injection (Sodium Tetradecyl Sulfate Injection) in the United States. Sotradecol is approved by the U.
The Food and Drug Administration today announced the settlement of a court case against an Illinois firm involved last year in FDA's seizure of thousands of imported unapproved drugs, including those that were labeled in foreign languages and/or labeled as repacked.
The firm, Phil and Kathy's, Inc., a corporation doing business as Local Repack, Alliance Wholesale Distributor, and Local Pharmacy, signed on April 8 a consent decree in the United States District Court for the Northern District of Illinois agreeing to operate in full compliance with FDA's regulations. The signatories included Phillip R. Giannino, the president of Phil and Kathy's, and Frank Weaver, the firm's head of repackaging operations.
"FDA protects the health of Americans by enforcing laws designed to ensure the safety, effectiveness and quality of all medications on the U.S. market," said Dr. Lester M. Crawford, Acting FDA Commissioner. "Products that are illegally distributed outside this protective system pose a serious threat to patients."
FDA's inspections in 2003 revealed that Phil and Kathy's was importing and repacking drug products that were labeled in Spanish and Portuguese and not in accordance with FDA's approvals. In addition, the firm has repeatedly failed to comply with FDA's current good manufacturing practice (cGMP) requirements, which serve to ensure that every marketed drug is safe, effective and properly manufactured.
Under the consent decree, Phil and Kathy's is prohibited from manufacturing, labeling and distributing any article of drug until it meets certain conditions, the most important of which is the FDA's determination that the firm's repackaging operations comply with cGMP. In addition, Phil and Kathy's agrees not to repackage any foreign-labeled drugs or drugs that are in any manner inconsistent with FDA's standards for approval. In case the firm purchases, distributes, or imports any such products, the consent decree gives the government additional authority to seek monetary damages.
The consent decree does not deal with the charges against Genendo Pharmaceutical, N.V., the importer of several drugs to Phil and Kathy's, which are still pending.