FDA bars firm from distributing unapproved cold medicines
WASHINGTON -- Federal regulators have secured a court order barring a New Jersey pharmaceutical company from distributing more than 50 unapproved cough and cold medicines.
The Food and Drug Administration said Friday that East Windsor, N.J.-based Advent Pharmaceuticals continued to market the medications despite prior warnings from regulators. The company also failed to correct numerous manufacturing problems identified by FDA inspectors.
Drug manufacturers in the U.S. are required to submit their products to the FDA for premarket approval to guarantee they are safe and effective. The unapproved products marketed by Advent and its subsidiary Neilgen Pharmaceuticals include: BP Allergy Junior Suspension, RE All 12 Suspension and many others.
Neilgen, which also does business as Unigen Pharmaceuticals, is based in Westminster, Md.
"Consumers in possession of these products should discontinue using them and discuss FDA-approved treatments with their health care professional," the FDA said in a statement.
Company executives Bharat Patel and Pragna Patel agreed to destroy their inventory of unapproved drugs, under a consent degree handed down in the U.S. District Court of Maryland. The agreement also bars the executives from manufacturing any new drugs without FDA approval and requires them to hire outside consultants to assess their operations before resuming production.
Company leaders did not immediately respond to calls for comment Friday afternoon.
Friday's action comes the same week the FDA ordered a number of medical device manufacturers to submit data on products that were never approved. The devices, which range from pacemaker generators to dental implants, were released to market before the 1976 law which gave FDA authority to regulate new devices.
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