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 “But it would be three games winning on the trot before we would even consider ourselves being able to start to feel a little bit safe. “Even if we win the game at West Brom, it’s a nice start, it’s a good start, but we are still in that position.” It has been lost on no-one that, whatever happens this weekend, Allardyce, just like Paolo di Canio, Gus Poyet and Advocaat before him, will go head-to-head with arch-rivals Newcastle in his second game at the helm with each of his immediate predecessors having sampled derby victory after losing their opening fixture. But Allardyce said: “Looking forward to the Newcastle derby will be a lot easier, a lot better for me, if the lads can go out and get a result at West Brom.” The former West Ham boss has made little secret of his immediate intention to shore up a defence which has conceded 18 goals in its first eight league games, including two against the Hammers last time out as they surrendered a 2-0 lead to draw. Allardyce will be without suspended duo Sebastian Coates and Jeremain Lens for the clash with the Baggies, but a man who both played and coach on Wearside earlier in his career is relishing his first game. Asked how he would feel when he heads for the dug-out, Allardyce replied: “Very proud. For whatever has happened here, there have been 40,000 fans turning up at home – I think it’s the seventh-highest attendance in the league and in all fairness, they haven’t had too much to cheer about. “But they keep wanting to turn up and they keep wanting to support the team, and obviously I have got to try to make sure they go home happy from now on, make sure they come and look forward to the next game because they have seen us win.” Sam Allardyce admits it could take three successive wins for Sunderland to start feeling like they can drag themselves out of Barclays Premier League relegation trouble. Press Associationcenter_img The 60-year-old will send the team he inherited from Dick Advocaat out for the first time at West Brom on Saturday, when even a victory would only be the start for a team five points adrift of safety and without a win in their opening eight league games. Allardyce said: “Every game is enormous for us. We will have to be consistent, we will have to be resilient, we will have to be mentally tough in terms of believing in ourselves to try to get ourselves out of this position because in all honesty, winning three games on the trot is going to be very difficult for us. last_img read more