FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation
The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data
FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
FDA approves first treatment for rare blood disease
The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
FDA approves first treatment for pediatric patients with lupus
FDA approves Benlysta for treatment of children with systemic lupus erythematosus (SLE), a chronic disease causing inflammation and damage to tissue and organs (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
FDA approves device to help increase access to more lungs for transplant
The device enables doctors to better assess lungs that were initially deemed to be unsuitable for transplant (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply
Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength). (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 26, 2019 Category: Food Science Source Type: news
FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes
“Remove the Risk” to raise awareness about proper disposal of prescription opioids (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 25, 2019 Category: American Health Source Type: news
Legacy Pharmaceutical Packaging, LLC Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity Found in the Active Pharmaceutical Ingredient (API)
Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 25, 2019 Category: Food Science Source Type: news
Jurox Incorporated is Voluntarily Recalling Two Lots of Alfaxan Unpreserved, an Intravenous Injectable Anaesthetic
This recall has been initiated due to an out of specification result for clarity observed in the stability program.
The presence of the aluminum phosphate precipitate presents a potential risk that intravascular (I.V.) injection of product containing this precipitate could result in blood vessel in (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 24, 2019 Category: Food Science Source Type: news
Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA ’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 23, 2019 Category: American Health Source Type: news
Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency ’s new steps to strengthen the process of initiating voluntary recalls
New steps to strengthen the process of initiating voluntary recalls (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 23, 2019 Category: American Health Source Type: news
Statement from Peter Marks, M.D., Ph.D., director of FDA ’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine
The FDA wants to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. MMR vaccine has been approved in the U nited States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in the United...
Source: Food and Drug Administration - April 22, 2019 Category: American Health Source Type: news
Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling
Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 21, 2019 Category: Food Science Source Type: news
FDA permits marketing of first medical device for treatment of ADHD
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 19, 2019 Category: American Health Source Type: news
FDA approves first generic naloxone nasal spray to treat opioid overdose
FDA granted approval of the 1st generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 19, 2019 Category: American Health Source Type: news
