The U.S. Food and Drug Administration approved Surfaxin ( lucinactant ) for the prevention of respiratory distress syndrome ( RDS ), a breathing disorder that affects premature infants. The lungs of premature infants are not able to make enough surfactant, a liquid that coats the inside of the lungs and helps to keep them open. Without enough surfactant, the lungs collapse and the infant has difficulty breathing. Most babies who develop RDS show signs of breathing problems and a lack of oxygen at birth or within the first few hours after birth. Surfaxin is the fifth drug approved i...

The U.S. Food and Drug Administration issued a warning letter to Breathable Foods Inc., makers of AeroShot , for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the use of AeroShot by children and adolescents and in combination with alcohol. The company claims AeroShot is designed to provide “breathable energy, anytime, anyplace.” The company also claims on its website that its product is intended to be ingested by swallowing. T...

The U.S. Food and Drug Administration approved the first generic versions of Boniva ( ibandronate ) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.

The Food and Drug Administration issued a proposed rule that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices. Nucleic acid-based tuberculosis tests can detect the presence of copies of tuberculosis bacterium genetic materials (RNA or DNA) in a mucus (sputum) sample obtained from the patient. This allows timely identification of TB disease. Currently, the...

The U.S. Food and Drug Administration approved the first generic Lexapro ( escitalopram tablets) to treat both depression and generalized anxiety disorder in adults.

The Food and Drug Administration approved GINTUIT , the first cell-based product made from allogeneic human cells (from a donor unrelated to the patient) and bovine collagen.

FluMist Quadrivalent , a vaccine to prevent seasonal influenza in people ages 2 years through 49 years, has been approved by the U.S. Food and Drug Administration.

Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration. These products, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol). The products include: Lipitor ( atorvastatin ), Lescol ( fluvastatin ), Mevacor ( lovastatin ), Altoprev ( lovastatin extended-release), Livalo ( pitavastatin ), Pravachol ( pravastatin ), Crestor ( rosuvastatin ), and Zocor ( simvastatin ). Combination products include: Advicor (...

Korlym ( mifepristone ) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome.

Regeneca , Inc. notifed the public of a nationwide recall of RegenArouse , Lot Number 130100. FDA lab analysis confirmed the presence of Tadalafil , an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making this product an unapproved new drug.