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_imgThe Zagreb Tourist Board has announced a public call for applications for co-financing of projects, events, marketing projects, gatherings and candidacies in 2019, whereby applications for co-financing in 2019 are collected through online application form  Special attention will be paid to: quality of project elaboration, ie detailed description, possibilities and independence of implementation, really expected result, involvement of various participants in the project, international impact of the project, contribution of the project to positioning Zagreb as a modern and urban destination and preservation of cultural heritage. the sustainable nature of the project and the innovative way of thinking. Criteria that will be evaluated for approving financial support of the Zagreb Tourist Board for projects and congress activities in 2019 are: Number of arrivals and overnight stays of domestic and foreign visitors related to the project, visitors whose main motive is visit to the event / project, value of media announcements in foreign and domestic media, enrichment of the tourist offer, budget, number of visitors / users of the project, tradition of the project, acceptance and sustainability, ability of the organizers, cooperation with travel agencies and overall assessment of the project and feasibility.Photo: Zagreb Light Festival The aim of co-financing is to encourage the development of existing and create new projects that increase the number of arrivals and overnight stays in the destination, enrich the tourist offer of the destination and promote the tourist product of Zagreb. “In this way, we want to develop the tourist product of the city of Zagreb – both the one that generates arrivals and the one that creates an atmosphere during the stay in the destination. At the same time, the goal of co-financing are projects aimed at promoting the city of Zagreb and projects related to the congress industry. ” stand out from TZGZ. Applications for co-financing in 2019 are collected via the Form located at the following link: http://digitalna-prijava.tzgz.hr , and the last day by which you can apply for the project, ie upload the Form to the online system is September 14, 2018. See the attachment for more details.Side dish: TZGZ Public call for collecting applications for co-financing in 2019last_img read more

first_img Sharing is caring! 32 Views   no discussions Share Tweet Sharecenter_img Chef Dereck Went. Photo credit: demerarawaves.comBRIDGETOWN, Barbados — “Cut back on table salt!” That’s the message from a Barbadian chef and entrepreneur who wants Caribbean people to abstain from over-consuming salty foods following reports of tragic life-altering strokes and other serious medical conditions.Chef Derek Went of Went Caribbean, a company that offers healthy Caribbean lifestyle support, said while the Caribbean region is known worldwide for its culinary exploits and some of the most flavour-filled foods, the region was playing “Russian Roulette” with its food preparation and consumption habits.Went Caribbean is keenly focused on reducing the high incidence of chronic, non-communicable diseases by offering a variety of products and services which promote a healthy lifestyle.“I am all for maintaining the diverse culinary traditions of the Caribbean, but let’s make sure we do so without compromising good health,” Went asserted, proposing a switch from table salt to moderate amounts of sea salt as a healthier alternative.The Caribbean chef promotes sodium-free, healthy spices and herbs in Barbados, across the Caribbean, and soon to the Caribbean Diaspora communities in North America. In addition to avoiding excessive quantities of salt present in today’s over-consumed processed foods, he also urged drinking pure water, checking blood pressure, daily exercise and other dietary habits — as recommended by medical doctors and qualified nutritionists — which were key to a healthier Caribbean and an economically sustainable health care system.Went Caribbean, supported by the Barbados Entrepreneurs Venture Capital Fund (known as BIM Ventures), promotes its WentWorx line of all natural, aromatic seasoning blends that contain no salt, no sugar, no MSG and no artificial preservatives. “You can definitely reduce the salt in your meals without sacrificing authentic Caribbean flavour when you use WentWorx blends,” he emphasized.WentWorx products currently contain naturally occurring sodium in health sustaining proportions.Caribbean News Now Share Food & DiningLifestyle Reduce salt intake, says Barbados chef by: – September 19, 2011last_img read more

first_imgA popular local priest has revealed how he literally fell into becoming a member of the RNLI.Fr Liam Boyle is the latest member of the lifeboat service based on Arranmore Island.Fr Boyle, who is originally from Fanad, had never been at sea before until curiosity took him to inspect the Arranmore lifeboat at the local pier several months ago. “I literally went over to have a look at the boat. I almost fell down the steps of the pier and the lads showed me around the boat.“I joked about becoming a member and the lads said “why not?” I thought nothing more of it then but as the months passed I thought a little more about it and decided to undertake the training.“And now I am a full volunteer and ready to answer emergency calls,” revealed Fr Boyle.To date the curate has been out on four emergency calls as part of the dedicated 21 member lifeboat crew based in the island who are all kitted with emergency pagers. He has missed a number of calls due not to responding as quickly as other responders as is the case.Fr Boyle with fellow RNLI crew members on Arranmore.The last which Fr Boyle took part in was to a stricken yacht belonging to a Canadian couple which had gone aground off the coast of Donegal a few weeks back.Thankfully Fr Boyle and his fellow crew members, assisted by the Rescue 118 helicopter and the Killybegs lifeguard, managed to lead the couple to safety.“It a real rush of adrenalin to be woken by your emergency beeper at 4.15am and to take to rough seas and not to return home until 10am the following morning.“Thankfully it ended well and everyone returned home safely in the end,” he said. Fr Boyle said he had absolutely no seafaring experience before he became curious about becoming a member of the RNLI on the island.In fact, the only time he had been on water was on a paddling lake “in a tub” in the nearby lake in Dunlewey.He says that people understand that his duties are to his parishioners on the island first and foremost but he also recognises the responsibility he now has to the RNLI.On the boat he says his fellow lifeboat crew members do not give him any special treatment and he is not always referred to as Fr Boyle. “They sometimes call me different names than that but I can’t repeat those,” he laughed.Fr Boyle says due to his vocation he does not know where his future postings will take him but he is looking forward to the immediate future on the island among its 550 strong population and fulfilling his role as a member of the RNLI.Popular priest finds his ‘sea legs’ with challenging RNLI role was last modified: November 9th, 2016 by StephenShare this:Click to share on Facebook (Opens in new window)Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Reddit (Opens in new window)Click to share on Pocket (Opens in new window)Click to share on Telegram (Opens in new window)Click to share on WhatsApp (Opens in new window)Click to share on Skype (Opens in new window)Click to print (Opens in new window)last_img read more