The much-anticipated announcement will mean that only tobacco, mint and menthol e-cigarette flavors can be sold at most traditional retail outlets such as convenience stores. The FDA also plans to seek a ban on menthol cigarettes, a longtime goal of public health advocates, as well as flavored cigars. FDA Commissioner Scott Gottlieb said the moves are meant to prevent young people from continuing to use e-cigarettes, potentially leading to traditional cigarette smoking.
Among the measures outlined by Commissioner Scott Gottlieb Thursday, the FDA would restrict sales of most types of flavored e-cigarettes to specialized vaping stores and online retailers who verify a purchaser’s age. The FDA also plans to draw up a ban on traditional menthol-flavored cigarettes and wants to eventually eliminate flavored cigars, which are popular with many younger smokers. The moves are part of a broader push by Gottlieb to reduce smoking and nicotine use.
Novartis AG said on Friday the U.S. Food and Drug Administration expanded the use of its low platelets drug to treat patients with a rare, genetic blood disorder. The drug, Promacta, received the green light as a combination with standard immunosuppressive therapy to treat patients two years and older suffering from treatment-resistant severe aplastic anemia (SAA). SAA is a blood disorder in which a patient's bone marrow fails to produce enough red blood cells, white blood cells and platelets.
The Food and Drug Administration has come down hard on StemGenex, a La Jolla, Calif., clinic pitching stem cell treatments for multiple sclerosis, diabetes, Parkinson's and other conditions. In a warning letter made public Tuesday, the FDA says that StemGenex's marketing is illegal, and that its manufacturing procedures are "putting patients at risk." The agency also said that there's no evidence that StemGenex followed up or investigated "multiple complaints involving possible adverse effects" of its treatments experienced by patients. The agency says that StemGenex could be subject to further action including "seizure, injunction, or prosecution" if it doesn't correct roughly 20 "objectionable conditions" or deviations from acceptable practice that its inspectors discovered during visits to the facility in January.
SILVER SPRING, Md., Nov. 16, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration is committed to animal welfare in research by reducing, replacing and/or refining the use of animals in research, whenever possible. The aim is this: by doing a single study to help establish a non-animal based model, we can potentially replace much of the need to use dogs in future trials with new informatics tools. The proposed study we are announcing today is part of the FDA's overall efforts to help reduce reliance on animals used for research conducted by the agency's scientists, as well as research conducted by industry.
SILVER SPRING, Md., Nov. 16, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers' diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. Travelers' diarrhea is the most common travel-related illness, affecting an estimated 10 to 40 percent of travelers worldwide each year.
SILVER SPRING, Md., Nov. 16, 2018 /PRNewswire/ -- Last month, the U.S. Department of Agriculture and the U.S. Food and Drug Administration held a public meeting to discuss the use of livestock and poultry cell lines to develop cell-cultured food products. At this meeting, stakeholders shared valuable perspectives on the regulation needed to both foster these innovative food products and maintain the highest standards of public health. After several thoughtful discussions between our two Agencies that incorporated this stakeholder feedback, we have concluded that both the USDA and the FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry.
Solid performance of approved drugs like Eylea and Dupixent along with an encouraging pipeline progress improve Regeneron's (REGN) market position.
DRRX is also eligible for single-digit percentage earn-outs based on U.S. sales of PERSERIS. Indivior indicated that they expect to have initial quantities available in Q4 ’18 and, based on the outcome of an appeal by Dr. Reddy’s lab (DRL) challenging the U.S. District Court of New Jersey’s preliminary injunction (PI) prohibiting DRL from importing or selling its generic buprenorphine/naloxone sublingual film product, expect to commence a full product launch. A favorable outcome (i.e.
Seattle Genetics' (SGEN) Adcetris gets Breakthrough Therapy designation by the FDA for the frontline treatment of certain lymphoma subtypes.
Dr Reddy's said Friday the US drug regulator has completed the audit of its Srikakulum plant with zero observations. "...the audit of our Formulations Srikakulum Plant (SEZ) Unit II, Andhra Pradesh by the US FDA, has been completed today with zero observations," Dr Reddy's said in BSE filing. Shares of Dr.Redyy's closed at Rs 2,470.85 a unit, up by 0.36 per cent compared to the previous close, at BSE on Friday.
WARREN, N.J., Nov. 16, 2018 /PRNewswire/ -- Aquestive Therapeutics, Inc. (AQST) today announced it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in regards to its New Drug Application (NDA) for tadalafil oral film (OF). Tadalafil is a PDE5 inhibitor currently marketed in tablet form for the treatment of erectile dysfunction and benign prostatic hyperplasia (BPH) under the brand name Cialis®, and for treatment of pulmonary arterial hypertension under the brand name Adcirca®. In the letter, the FDA requested limited additional data from healthy volunteers.
The FDA announced a new plan for a nationwide crackdown on teenage use of e-cigarettes. The organization is ordering stores that sell fruity e-cigarettes to physically wall them from teen shoppers and to verify every customer is at least 18 years old.
The U.S. Food and Drug Administration (FDA) announced on November 14, 2018, that it has filed a Food Additive Petition (FAP) to amend its food additive regulations to remove the clearances for 26 ortho-phthalates due to abandonment by industry. The FAP was filed on July 3, 2018 by the Flexible Vinyl Alliance (FVA). By way of background, on April 12, 2016, FDA accepted for consideration a separate FAP submitted by a group of nongovernment organizations (NGOs) that called on the Agency to revoke the same clearances for the 26 ortho-phthalates, in addition to four others, because they are not safe for use in food-contact applications. (See the PackagingLaw.com article, FDA Files Petition to Revoke