Altan Pharma Submits New Drug Application for Acetaminophen Solution for Infusion for Treatment of Pain and Reduction of Fever
Altan Pharma Limited (“Altan”), an Irish specialty pharmaceutical company, today announces that it has submitted a New Drug Application (NDA) for its formulation of acetaminophen solution for infusion to the United States Food and Drug Administration (FDA) and that it has been accepted for review. The NDA was submitted pursuant to section 505(b)(2) of the Food, Drug and Cosmetic Act.
Acetaminophen Solution for Infusion is an analgesic used to treat mild to moderate pain in adult and pediatric patients two years and older, moderate to severe pain in conjunction with adjunctive opioid analgesics in the same population and for the reduction of fever in adult and pediatric patients.
Traditional intravenous formulations of acetaminophen are extremely sensitive to oxygen, requiring them to be deoxygenated in the manufacturing process and to be packaged in glass vials to maintain stability throughout their approved shelf life. Altan has developed a unique, ready-to-use formulation that does not require deoxygenation and that can be packaged in flexible plastic containers, which are preferred by hospitals.
Altan announced last April that the United States Patent and Trademark Office (“USPTO”) had awarded the Company two patents covering its unique formulation of intravenous acetaminophen. These patents will provide protection for Altan’s intravenous formulation of acetaminophen until July 18, 2026. In addition to the US patents, Altan holds patents on its formulation of intravenous acetaminophen in Canada, Japan, Australia, South Africa, France, Germany, Spain, Italy, and the UK as well as most other European countries. Altan has manufactured and sold more than 200 million units of its intravenous acetaminophen formulation in the above non-US markets.
According to IMS, the US market for intravenous acetaminophen is around 10 million units, or $300 million annually. The US market is currently dominated by one supplier that holds a patent on the process for deoxygenating intravenous formulations. By contrast, Altan’s process for producing Acetaminophen for infusion does not require deoxygenation and therefore offers the potential for an alternative solution in the US market.
Guillermo Herrera, CEO of Altan said: “We are delighted that the FDA has accepted our registration package for review. If marketed, our product has the potential to offer a superior, more economically favorable solution for hospitals, patients and payors”.
About Altan Pharma Ltd.
Altan Pharma Ltd. is a privately held, specialty pharmaceutical company that develops, manufactures and commercializes injectable drugs for the hospital and other provider segments. Altan has a broad geographic footprint covering many European, Latin American and Asian markets. The company is highly focused on building its pipeline of injectable drugs and expanding its commercial presence to new markets, including the United States, through both organic and inorganic means. Altan’s Lead Investors are Malin Corporation plc (Euronext Dublin: MLC) and Lake Forest Pharma Investments, LLC.
Forward Looking Statements
This press release contains “forward-looking statements” subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict, including the difficulty of predicting FDA approvals, acceptance and demand for pharmaceutical products, the impact of competitive products and pricing, new product development and launch, the regulatory environment, etc. This press release is made only as of the date hereof, and unless otherwise required by applicable securities laws, Altan disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information visit www.altanpharma.com
Altan Media Relations Contact
Tel: + 353 1 908 1280
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
FDA Approves OTEZLA® (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease19.7.2019 20:59:00 EEST | Press release
Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. OTEZLA, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only approved treatment option for oral ulcers associated with Behçet’s Disease, a rare, chronic, multisystem inflammatory disease that is difficult to treat. “Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behçet’s Disease, and have an important negative impact on the quality of life for these patients,” said Yusuf Yazici, M.D., Clinical Associate Professor, Department of Medicine, New York University Langone Health. “In the clinical trial, OTEZLA demonstrated improvements in measures of oral ulcers at week 12. OTEZLA has the potential to be a needed treatment option for U.S. patients and their physicians, who
Abiraterone Acetate Included in World Health Organisation’s Essential Medicines List for the Treatment of Metastatic Castration-Resistant Prostate Cancer19.7.2019 16:05:00 EEST | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson is delighted with the recent announcement from the World Health Organisation (WHO) to include abiraterone acetate (ZYTIGA ® ) for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in the updated Essential Medicines List, published on 9th July 2019.1,2 The WHO’s Essential Medicines List is a core guidance document that helps countries prioritise critical health products that are recommended to be widely available and affordable throughout health systems.1 “The inclusion of abiraterone acetate in the WHO Essential Medicines List highlights the critical role that this treatment can play in improving the lives of patients living with mCRPC and their families,” said Dr. Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. “I am proud that we are working hard to impact survival and quality of life by developing and providing innovative medicines which ar
Gilead Sciences Licenses Respiratory and Herpes Antiviral Research Programs From Novartis19.7.2019 15:30:00 EEST | Press release
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that it has licensed three preclinical antiviral programs from Novartis, including investigational agents with the potential to treat human rhinovirus, influenza and herpes viruses. Under the agreement, Gilead will acquire exclusive global rights to develop and commercialize novel small molecules against three undisclosed targets. Novartis will receive an upfront payment and is eligible to receive up to an additional $291 million in potential milestone payments upon achievement of certain development and commercial milestones, as well as royalties on annual net sales. “Today’s announcement builds on Gilead’s heritage in antiviral research and development. We look forward to applying this expertise to advance the development of potential new treatments for viruses with limited therapeutic options,” said John McHutchison AO, MD, Gilead’s Chief Scientific Officer and Head of Research and Development. Gilead’s antiviral portfolio include
Schlumberger Announces Second-Quarter 2019 Results19.7.2019 14:00:00 EEST | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2019. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2019 Mar. 31, 2019 Jun. 30, 2018 Sequential Year-on-year Revenue $8,269 $7,879 $8,303 5% 0% Pretax segment operating income $968 $908 $1,094 7% -12% Pretax segment operating margin 11.7% 11.5% 13.2% 17 bps -148 bps Net income - GAAP basis $492 $421 $430 17% 14% Net income, excluding charges & credits* $492 $421 $594 17% -17% Diluted EPS - GAAP basis $0.35 $0.30 $0.31 17% 13% Diluted EPS, excluding charges & credits* $0.35 $0.30 $0.43 17% -19% North America revenue $2,801 $2,738 $3,139 2% -11% International revenue $5,463 $5,037 $5,065 8% 8% North America revenue, excluding Cameron $2,243 $2,178 $2,546 3% -12% International revenue, excluding Cameron $4,761 $4,469 $4,387 7% 9% *These are non-GAAP financial measures. See section titled "Charges & Credits" for details. Schlumberger Chairman and CEO Paal Kibsgaard commente
Schlumberger Appoints Olivier Le Peuch as CEO19.7.2019 13:46:00 EEST | Press release
Schlumberger Limited (NYSE: SLB) announced today that its Board of Directors has appointed Olivier Le Peuch as its Chief Executive Officer and member of the Schlumberger Board, effective August 1, 2019. Mr. Le Peuch succeeds Paal Kibsgaard, who will retire as Chief Executive Officer effective that same date. Also effective August 1, Mr. Kibsgaard will step down as Chairman of the Board and retire as a member of the Board of Directors. Mr. Kibsgaard will retire after more than 22 years of service to the Company, including eight years as CEO and four years as Chairman. Effective the same date, Mark G. Papa, a current non-independent director, will become non-executive Chairman of the Board. Peter Currie will continue to serve as the Board’s Lead Independent Director. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190719005161/en/ Olivier Le Peuch is appointed Chief Executive Officer and a member of the Schlumberger Board, effe
Fluke Corporation Acquires Industrial Reliability Leader PRÜFTECHNIK19.7.2019 13:00:00 EEST | Press release
Fluke Corp., the global leader in test and measurement instruments, has acquired Ismaning, Germany-based PRÜFTECHNIK, a market leader in precision laser shaft alignment, condition monitoring, and non-destructive testing. “Fluke’s acquisition of PRÜFTECHNIK reflects the growing importance our customers place on reliability systems to keep their equipment in optimum operating condition,” said Marc Tremblay, president of Fluke Corporation. “This business will help us usher in the next generation of solutions for our industrial customers.” Fluke Corporation For information on Fluke tools and applications, or to find the location of your nearest distributor, contact Fluke Corporation, P.O. Box 9090, Everett, WA USA 98206, call (800) 44-FLUKE (800-443-5853), fax (425) 446-5116, e-mail firstname.lastname@example.org or visit the Fluke Web site at http://www.fluke.com. About Fluke Founded in 1948, Fluke Corporation is the world leader in compact, professional electronic test tools and software for measu
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom