FDA News

FDA Warns Against Unapproved Erectile Dysfunction Products

FDA Warns Against Unapproved Erectile Dysfunction Products

Unapproved erectile dysfunction drugs are touted as a "healthy man alternative to the little blue pill."

NCCN Recs Go Beyond FDA-Approved Indications

NCCN Recs Go Beyond FDA-Approved Indications

NCCN recommended 47 FDA-approved drugs for 113 indications; 39% were extra recommendations

FDA Approves New Treatment for Drug-Resistant HIV

FDA Approves New Treatment for Drug-Resistant HIV

Trogarzo is given intravenously once every 14 days in combination with other antiretrovirals

FDA Purging Kratom Products

FDA Purging Kratom Products

Missouri-based Divinity Products Distribution will recall and destroy kratom-containing products

Clarithromycin May Damage Heart, FDA Warns

Clarithromycin May Damage Heart, FDA Warns

Agency advising doctors to consider prescribing other antibiotics to patients with coronary heart disease

Botanical Kratom Contains Opioids, FDA Warns

Botanical Kratom Contains Opioids, FDA Warns

Calls to poison centers regarding kratom increased 10-fold between 2010 and 2015

FDA Approves Short Acting Insulin Drug for Diabetes

FDA Approves Short Acting Insulin Drug for Diabetes

The FDA just approved a new short-acting insulin drug, Admelog, for patients with either T1D or T2D.

FDA Approves Semiglutide for Type 2 Diabetes

FDA Approves Semiglutide for Type 2 Diabetes

Semaglutide helps patients with diabetes reduce blood glucose levels and lower body weight.

Drug Approved for Complicated Urinary Tract Infections

Drug Approved for Complicated Urinary Tract Infections

Vabomere, which combines meropenem and vaborbactam, demonstrated superior efficacy to piperacillin/tazobactam.

FDA May Lower Nicotine Levels in Cigarettes to Non-Addictive Levels

FDA May Lower Nicotine Levels in Cigarettes to Non-Addictive Levels

The FDA is delaying implementation of last year's rules on cigars and electronic cigarettes currently on the market until 2021 and 2022, respectively.

FDA Will Increase Generic Drugs

FDA Will Increase Generic Drugs

The agency will now give priority reviews to new generic drugs until there are 3 on the market.

FDA: Canagliflozin May Increase Risk of Foot, Leg Amputations

FDA: Canagliflozin May Increase Risk of Foot, Leg Amputations

Amputations of the toe and middle of the foot were the most common, but leg amputations below and above the knee also occurred.

Anemia Indication Sought for Phosphate Binder

Anemia Indication Sought for Phosphate Binder

Company asks FDA to approve ferric citrate for iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease.

First Drug Approved to Treat Nocturnal Polyuria

First Drug Approved to Treat Nocturnal Polyuria

Noctiva is taken 30 minutes before bed and is designed to increase absorption of water through the kidneys.