Business Wire

Philip Morris International (PMI) Files Premarket Tobacco Product Application for its Electronically Heated Tobacco Product (EHTP) with the US Food and Drug Administration (FDA)

31.3.2017 15:13 | Business Wire

Del

Philip Morris International Inc. (“PMI”) (NYSE / Euronext Paris: PM) submitted a Premarket Tobacco Product Application (PMTA) for its Electronically Heated Tobacco Product (EHTP) to the US Food and Drug Administration’s (FDA) Center for Tobacco Products. This is consistent with the Company’s stated goal of submitting its PMTA in the first Quarter of 2017.

PMI’s PMTA seeks authorization to commercialize the EHTP in the United States. Should FDA grant the requested marketing order, Altria Group Inc. would be responsible for commercializing and marketing the product in the United States under the terms of a licensing agreement with PMI.

Note to editor

On December 5, 2016, PMI submitted a Modified Risk Tobacco Product (MRTP) application for its EHTP to the FDA. Administrative review of that application is ongoing. A PMTA marketing order is a prerequisite to commercializing a new tobacco product such as PMI’s EHTP. A decision on the PMTA would allow the marketing of PMI’s EHTP without modified risk claims independent of a decision on the MRTPA.

Philip Morris International Inc.

Philip Morris International Inc. (PMI) is the world’s leading international tobacco company, with six of the world's top 15 international brands and products sold in more than 180 markets. In addition to the manufacture and sale of cigarettes, including Marlboro, the number one global cigarette brand, and other tobacco products, PMI is engaged in the development and commercialization of Reduced-Risk Products (RRPs). RRPs is the term PMI uses to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continued smoking. Through multidisciplinary capabilities in product development, state-of-the-art facilities, and industry-leading scientific substantiation, PMI aims to provide an RRP portfolio that meets a broad spectrum of adult smoker preferences and rigorous regulatory requirements. For more information, see www.pmi.com and www.pmiscience.com

Contact information

Media enquiries
Philip Morris International Media Office
T: +41 (0)58 242 4500
E: media@pmi.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

IFF to Present at the Barclays Global Consumer Staples Conference21.8.2017 20:15Pressemelding

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF), a leading innovator of sensory experiences that move the world, today announced that Andreas Fibig, Chairman and Chief Executive Officer will present at the Barclays Global Consumer Staples Conference in Boston, MA on Thursday, September 7, 2017 at 11:15 a.m. EDT. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF) is a leading innovator of sensorial experiences that move the world. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what if?”. That passion for explorati

Celularity, Inc., Accelerates Breakthrough Placental Discovery & Therapeutic Platform21.8.2017 20:11Pressemelding

Celularity, Inc., a newly formed biotechnology company, today announced its acceleration of cell and tissue regenerative therapies to address unmet medical needs in cancer and chronic and degenerative disease. Celularity completed their Series A financing with contributions from several biopharma companies, including Sorrento Therapeutics, United Therapeutics Corporation and Human Longevity, Inc., and entrepreneurial investors. Celularity has been created through the contributions of extensive intellectual property, clinical-stage assets, basic and clinical research, and development expertise including: Several clinical-stage immuno-oncology and regenerative medicine assets and a pipeline of pre-clinical assets Proprietary allogeneic (“readily accessible”) immunotherapy platform 200+ issued and pending patents in cell therapy

European Commission Grants New Indication for Soliris® (Eculizumab) for the Treatment of Patients with Refractory Generalized Myasthenia Gravis (gMG)21.8.2017 13:25Pressemelding

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the European Commission (EC) approved the extension of the indication for Soliris® (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Soliris is the first and only complement-based therapy approved in the European Union (EU) for this ultra-rare subset of patients.1-4 Patients with refractory gMG can have difficulties walking, talking, swallowing and breathing normally despite therapies currently used for MG. Exacerbations and crises of their disease may require hospitalization and intensive care and may be life-threatening.5-7 Soliris will be launched for this new indication initially in Germany, and Alexion is evaluating launches in additional EU countries. “Patients with refractory gMG have exhausted multiple the

IntegenX Applauds the Passage of the Rapid DNA Act of 201721.8.2017 12:00Pressemelding

IntegenX Inc., the global market leader for Rapid DNA human identification, applauds the signing into law of S.139 and HR.510, The Rapid DNA Act of 2017. The legislation will allow law enforcement agencies, under standards and guidelines established by the FBI, to perform real-time DNA testing at time of arrest, within booking stations. Similar to how fingerprint analysis has evolved from a paper and ink practice to a point-of-action technology, DNA testing has now become possible in 90 minutes within a booking station, while a suspect is still in custody. With processing times reduced from weeks to less than two hours, the potential to identify or exonerate a suspect quickly will make a meaningful impact on law enforcement. IntegenX thanks U.S. Senate sponsor Senator Orrin Hatch (R-UT) and lead co-sponsor Senator Dianne Feinstein (D-CA) as well as House sponsor Congressman

PPG Completes COLORFUL COMMUNITIES Project at Primary School in Kecskemét, Hungary21.8.2017 08:03Pressemelding

PPG (NYSE:PPG) today announced the completion of a COLORFUL COMMUNITIES™ project in Kecskemét, Hungary, that helped revitalize the learning environment of the Corvin Mátyás primary school. The Colorful Communities program provides PPG volunteers and products along with financial contributions to bring color and vitality to communities where the company operates around the world, such as in Kecskemét, where the PPG automotive service team operates with 33 employees. The project brought together more than 140 PPG and community volunteers who spent three days at the school revitalizing four classrooms, four changing rooms and the playground. PPG provided more than $20,000 to assist with the project, including more than 460 liters of Héra ® Prémium waterborne interior paint and Trinát ® Aqua wate

Glennmont Partners Completes Refinancing of Sleaford Biomass Plant for £150m21.8.2017 08:00Pressemelding

Glennmont Partners has successfully completed the refinancing of the Sleaford Renewable Energy Plant on behalf of its dedicated clean energy fund, Glennmont Clean Energy Fund Europe I, as part of a programme of realisations of value from the Fund. Glennmont Partners is one of Europe’s largest fund managers focusing exclusively on investment in clean energy infrastructure. Glennmont raises long-term capital to invest in alternative power generation projects including wind farms, biomass power stations, solar parks and small-scale hydro power plants. The carefully selected, risk managed investments deliver sustained performance and predictable returns over periods of 10 years or more. Sleaford REP is a 40MWe straw-fired biomass plant located in Lincolnshire, UK. The plant has been in operation since 2014 and is being operated by Burmeister & Wain Scandinavian Contractor (BWSC). The

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom