- Study: Whooping cough vaccine may not prevent infection
- GPhA: FDA’s proposed rule on prescription drug labeling adds $4 billion to healthcare costs
- FDA requests label and packaging changes for certain topical antiseptic products
- Reports: Bill to extend federal regulations for compounding pharmacies expected to pass House, Senate
- FDA issues sweeping new requirements for long-acting opioids
SWIFTWATER, Pa. A vaccine for a bacterial infection that affects the gastrointestinal tract has been granted expedited approval by the Food and Drug Administration.
French drug maker Sanofi-Aventis announced Tuesday that it had received fast-track designation from the FDA for its investigational Clostridium difficile vaccine. The FDA grants the designation to ease the development of new drugs and vaccines for serious or life-threatening conditions or unmet medical needs.
C. difficile infection, or CDI, is one of the most common hospital-acquired infections in the developed world. The bacteria are present without causing symptoms in around 60% of infants and 3% of adults. Antibiotic treatments sometimes can disrupt the bacteria in the gut, causing C. difficile to multiply and release toxins that cause the symptoms associated with CDI.