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An over-the-counter homeopathic anti-snoring nasal spray manufactured by Green Pharmaceuticals contained “gross microbial contamination,” including large numbers of the aerobic bacteria Providencia rettgeri, as well as yeast and mold, the FDA said in a warning letter to the company. Read More
The FDA handed Granules Pharmaceuticals’ Chantilly, Va., drug manufacturing facility a six-observation Form 483 for deficient quality control procedures and other production lapses following a July 18 to July 22 inspection. Read More
The FDA has accepted Harm Reduction Therapeutics’ (HRT) new drug application (NDA) for RiVive, an investigational over-the-counter (OTC) nasal spray containing 3 mg of naloxone, and has granted the compound a priority review. Read More
In a low-key pre-holiday move, the FDA converted three alternative dosing regimens of Merck’s blockbuster cancer drug Keytruda from accelerated to full approval, a move that is not likely to be questioned by critics of the accelerated approval pathway due to the wealth of safety data behind the drug. Read More