The U.S. Food and Drug Administration today approved Rapamune (sirolimus), to treat lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily affects women of childbearing age. This is the first drug approved to treat the disease.

The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

The U.S. Food and Drug Administration proposed a rule today that would require animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales by major food-producing species (cattle, swine, chickens and turkeys). The additional data would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials.

As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.”

As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.”

Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza System can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 KHz) and low stimulation amplitudes.

Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza System can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 KHz) and low stimulation amplitudes.

The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection. The agency approval for plague includes use of the drug for the treatment of pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood). Avelox is also approved for prevention of plague in adult patients.

The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection. The agency approval for plague includes use of the drug for the treatment of pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood). Avelox is also approved for prevention of plague in adult patients.

The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery.