News from the FDA
Dr. Mike brings you the latest news from the U.S. Food and Drug Administration including alerts, new drug approvals, new drug indications, and first time generic drug approvals.
The U.S. Food and Drug Administration (FDA) yesterday issued an import alert for generic drugs produced at two Ranbaxy Laboratories in India. Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States.
The FDA is concerned that these plants do not meet the FDA's safe drug manufacturing standards. However, FDA states that it has no evidence to date that Ranbaxy has shipped any defective products. Additionally, the FDA considers Ranbaxy generics already in the U.S. to be safe and the agency is not ordering any of the drugs in question to be removed from pharmacies.
The FDA “recommends that consumers continue taking their medications manufactured by Ranbaxy and not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.”
The FDA import alert includes some commonly subscribed generic medications, such as pravastatin and simvastatin used to treat high cholesterol; metformin and glimepiride used to treat type 2 diabetes; loratadine OTC used to treat allergies; and, fosinopril used to treat high blood pressure.
More Information from Dr. Mike:
- Drugs on Import Alert List
- FDA Ranbaxy Laboratories News Release
- Frequently Asked Questions About Generic Drugs