Initially it was 12 weeks time that was considered safe for using over the counter nicotine gums, patches and lozenges. But now on Monday, the Food and Drug Administration has approved an extended period for the same. FDA said that these over-the-counter products can be used for even a longer period of time but only with a doctor's approval.
A biotechnology firm, Pharmaxis, has received a letter from the US Food and Drug Administration (FDA) regarding a drug that treats cystic fibrosis.
The drug is labeled Bronchitol. This letter is in response to the permission asked by Pharmaxis from the agency. The company wanted the drug to be used by cystic fibrosis patients aged six and above.
U. S. Food and Drug Administration's panel of advisers gave a statement that they no longer support the use and marketing of `calcitonin salmon' for the treatment of osteoporosis in post-menopausal women. The panel voted the drug out of its recommendations that it potentially increases the risk of cancer more than the treatment of osteoporosis by bone-thinning.
After the death of a 14-year-old patient in a clinical trial because of Amgen's Sensipar, the Food and Drug Administration has given orders to restrict the use of Sensipar in pediatric patients' clinical studies. However, the agency has not revealed about the surety of the drug having killed the boy.