first_imgMylan Technologies Inc,Mylan Inc (Nasdaq: MYL) today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day. This product is the generic version of Vivelle-Dot®, which is indicated for the treatment of symptoms associated with menopause, the treatment of hypoestrogenism and the prevention of postmenopausal osteoporosis. Mylan has a plant in St Albans which manufactures Transdermal patches and pharmaceutical labels.Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for all strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the U.S. District Court for the Southern District of New York and the U.S. District Court for the District of Vermont.Vivelle-Dot had U.S. sales of approximately $215 million for the 12 months ending Dec. 31, 2010, according to IMS Health. Currently, Mylan has 169 ANDAs pending FDA approval representing $97.9 billion in annual sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $24.8 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.This press release includes statements that constitute “forward-looking statements,” including with regard to the expected first-to-file status and pending litigation. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the use of legal, regulatory and legislative strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company’s filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com(link is external). For more information about generic drugs, please visitwww.ChoosingGenerics.com(link is external).SOURCE Mylan Inc. PITTSBURGH, March 1, 2011 /PRNewswire/last_img read more

first_img Share 153 Views   no discussions MONTREAL, Canada (AFP) — Officials launched a meningitis vaccination campaign at a Canadian university Friday after detecting two cases of the infection, health authorities said.A student at Acadia University in the province of Nova Scotia was killed by the infection at the beginning of the month.Head of public health for the province, Robert Strang, announced the detection of a second strain B meningitis case at the university.“Two cases of the same strain of meningococcal meningitis in one location, such as a university campus, constitutes an institutional outbreak,” Strang said in a letter Friday.A vaccination campaign is being organised for the university’s several thousand students, he said.Meningitis is an infection that causes swelling around the brain and spinal cord that can quickly become fatal. It can be transferred by secretions from the nose and mouth.But the disease is not highly contagious, Strang said.“This disease does not spread through the air or through casual exposure,” he said in a letter to the university.The Government of Nova Scotia has placed an order for 10,000 vaccines for the vaccination campaign. A second injection will be given to students before the end of the semester.This is the fourth case of meningitis detected in Nova Scotia this year. Earlier, a grade schooler died from a different strain of meningitis in the province. Share HealthInternationalLifestylePrint Meningitis outbreak declared at Canada university by: Associated Free Press – February 14, 2015center_img Sharing is caring! Tweet Sharelast_img read more

first_imgVersailles, IN—Though the Veterans Day Parade and ceremony is canceled in Versailles due to the COVID-19 pandemic, the Versailles American Legion will be hosting several private ceremonies throughout the area over the weekend to honor deceased veterans. SaturdayVersailles American Legion will gather at 11 am at the Post Home and then proceed to Cliff Hill Cemetery to place flags on the graves of all the veterans. SundayAt 8:45 am members of the Versailles Legion will assemble and proceed to honor all deceased veterans buried at the area cemeteries. The schedule is :9:15am -Elrod9:30 am -Marble Corner9:45 am -Tanglewood10 am-Holton10:15 am -Shelby10:30 -New Marion10:45 am  -Benham11 am  -Olean-St. Pauls11:15 -Olean-St Peters 11:30 -Akers- Friendship11:45am  -Dewberry-St Pauls Lutheran12:15 pm  -Cross Plains12:30pm  -Salem1 pm -West Fork 1:15pm -Grandview Memorial GardensAll those who attend are encouraged to practice social distancing in accordance with the State of Indiana regulations.MondayLegionnaires will meet at the Post Home at 10:30 am and proceed to Cliff Hill Cemetery to honor our deceased veterans.  These services are not open to the public this year.last_img read more