Generics Industry News Search
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August 2009 News Archive |
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Genzyme Corp., a biotechnology company that develops drugs for rare chronic diseases, sued the Roxane Laboratories unit of Germany's Boehringer Ingelheim GmbH alleging infringement of a patent for the kidney drug Hectorol....
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Recently, a colleague of mine asserted that till date, GSK had obtained only one pharmaceutical product patent in India! Given that GSK has the largest sales in India (of all the MNC's operating within India) and have introduced most of their global products in India as well, this figure seems a tad too difficult to believe. Anyone in the know from amongst our readers?...
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Sun Pharmaceutical Industries Ltd announced today that it has, along with its subsidiaries (collectively, Sun Pharma), executed a settlement agreement with MedImmune, stipulating the dismissal of the lawsuits filed in the United States District Court for the District of Maryland regarding the submission of an Abbreviated New Drug Application for a generic version of Ethyol...
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Warner Chilcott Limited announced today that it has received two Paragraph IV Certification Notices from Lupin Ltd. (Lupin). The Paragraph IV Certification Notices advise the Company of the filing of Abbreviated New Drug Applications by Lupin for generic versions of the Company's oral contraceptives, Loestrin 24 Fe and Femcon Fe....
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Caraco Pharmaceutical Laboratories, Ltd. announces today that it has executed a settlement agreement with MedImmune, stipulating the dismissal of the lawsuits filed in the United States District Court for the District of Maryland regarding the submission of an Abbreviated New Drug Application (ANDA) for a generic version of Ethyol ...
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Pharmaceutical Patent Intelligence firm GenericsWeb today announced that it had achieved in excess of 30% growth in revenue over the past financial year ending June 30th 2009, despite facing tough economic circumstances due to the global financial meltdown. ...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration on its Abbreviated New Drug Applications for metoprolol succinate extended-release tablets USP in the 25 mg and 50 mg strengths....
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Perrigo Company today announced that its partner Teva Pharmaceutical Industries Ltd. has received final approval from the U.S. Food and Drug Administration to market Triamcinolone Acetonide Nasal Spray containing a paragraph IV certification....
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Swiss drug maker F Hoffmann La Roche Ltd - which trimmed prices of its valganciclovir hydrochloride drug used to treat HIV-related infections after India reduced import duty on it in April - is set to defend later this week its local patent for the drug against at least five post-grant oppositions at the Chennai patent office. ...
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Federal health advisers say generic drug companies should not have to conduct costly human trials before launching generic versions of ViroPharma's lead drug Vancocin, dealing a major setback to the company's gastrointestinal infection treatment....
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The European Commission has approved the generic version of Clopidogrel developed by Acino for marketing within the European Union ...
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Anchen Pharmaceuticals, Inc. announced today that today it received final approval from the FDA for the 500mg strength of Divalproex Sodium ER Tablets. Launch and shipment of the 500 mg product will begin immediately. Anchen's 250 mg strength Divalproex Sodium ER product received final FDA approval in February of 2009, and was launched immediately thereafter. Anchen's Divalproex Sodium ER Tablets are the AB-rated generic equivalent of Abbott Laboratories' DEPAKOTE ER product....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a ruling by the U.S. District Court for the District of New Jersey finding Bayer Schering's U.S. Patent No. 6,787,531 invalid. The patent is listed in the Orange Book for Bayer's oral contraception Yasmin...
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Impax Laboratories today confirmed that the U.S. Food and Drug Administration has granted final approval of the Company's Abbreviated New Drug Application for generic version of Depakote (divalproex ER) 500mg Extended-release Tablets. The Company received approval on the 250mg tablets in May 2009...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that one lot of 100 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies. The recalled patches are from Lot Number 145287A, have expiration dates of February 2011 and were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc. The affected lot of Fentanyl Transdermal System patches was shipped to customers between April 2, 2009 and May 20, 2009. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall....
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Glenmark Pharmaceuticals' patent challenge against Schering Plough's cholesterol-lowering drug Zetia will come up for hearing in the US district court of New Jersey on August 19....
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The European Union's seizure of generic drugs could imperil the global response to epidemics such as swine flu, India's commerce minister said yesterday....
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Aurobindo Pharma Limited is pleased to announce that it's tentatively approved ANDA for Sumatriptan Succinate Tablets 25 mg, 50 mg, and 100 mg (ANDA No. 78-327) has received the final approval from the US Food & Drug Administration (USFDA). ...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sumatriptan Succinate Tablets, 25 mg (base), 50 mg (base) and 100 mg (base). This product is manufactured in Mylan's Morgantown, W.VA. facility....
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Ranbaxy Laboratories Limited (Ranbaxy), announced today, that the Company has received final approval from the U.S. Food and Drug Administration to manufacture and market Sumatriptan Succinate Tablets, 25 mg (base), and 50 mg (base). The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Imitrex by GlaxoSmithKline. Total annual market sales for Sumatriptan Succinate 25 mg and 50 mg tablets were $379 million (IMS - MAT: June 2009) which is indicated for the acute treatment of migraine attacks with or without aura in adults.
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Teva Pharmaceutical Industries Ltd. today announced U.S. Food and Drug Administration (FDA) approval and launch of Oxaliplatin Injection. Teva's 505(b)(2) New Drug Application provides for the use of Oxaliplatin Injection, 50 mg/10 mL and 100 mg/20 mL for adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor and treatment of advanced colorectal cancer....
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Schering-Plough Corporation today announced an agreement with Orchid Chemicals & Pharmaceuticals Ltd. and Orgenus Pharma, Inc., related to the generic manufacturing of certain formulations of CLARINEX(R) (desloratadine). ...
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Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced U.S. Food and Drug Administration approval and launch of oxaliplatin injection in the United States. The medication is a generic version of Sanofi-Aventis' Eloxatin, which posted 2008 U.S. sales of approximately $1.4 billion. Hospira's oxaliplatin injection is one of the first generic versions of this drug to come in solution form. The innovator drug is also in solution form...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approvals for two Abbreviated New Drug Applications, generic version of Eloxatin, Oxaliplatin for injection and generic version of Imtrex, Sumatriptan succinate tablets. Sun Pharma shares 180 days exclusivity for generic version of Eloxatin...
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Sandoz today announced the introduction of Tacrolimus capsules, a generic equivalent of Prograf, in the US. Tacrolimus is an immunosuppressive treatment used to help prevent rejection of a kidney or liver transplant. ...
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Sun Pharmaceutical Industries has got the U.S. Food and Drug Administration's approval to launch its generic version of GlaxoSmithKline's Imitrex tablets to treat migraine, the Indian drugmaker said...
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The inspector general of the Department of Health and Human Services is investigating a conflict-of-interest allegation involving the official in charge of drug approvals at the Food and Drug Administration, the FDA said...
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The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd today announced that it has received the final approval from the US Food and Drug Administration for its drug Sumatriptan Succinate tablets
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The U.S. Food and Drug Administration said on Thursday it completed a probe into a key Mylan Inc manufacturing plant and found no deficiencies, clearing an issue that has hung over the world's No. 3 generic drugmaker. Its shares rose about 4 percent....
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Hospira Inc on Friday said U.S. regulators had suspended its approval, received only three days earlier, to sell a generic injectable formulation of Sanofi-Aventis' colon cancer drug Eloxatin....
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The results of Sun Pharmaceuticals Ltd for the quarter ended June were way below market expectations, with both domestic and export revenues falling. ...
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Wyeth has already stopped Sigma from moving forward with its generic. Last week it was in court again alleging patent infringement by Alphapharm's Enlafax XR and asking a Federal Court judge to stop the generic giant from marketing or PBS listing....
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The threat of biosimilars is a hot topic in the U.S. biotech market, but their introduction in Europe may reveal that their effects will be limited....
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The FDA and Barr Laboratories, Inc. have announced a recall for generic Adderall tablets that may contain more of the active pharmaceutical ingredients than they are supposed to have, posing a risk of serious side effects among users of the ADHD drug...
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Vasogen Inc. and IntelliPharmaCeutics (IPC) announced today that they have entered into a definitive agreement, subject to shareholder and regulatory approvals, whereby Vasogen will combine with IPC under a plan of arrangement and merger to continue as a publicly-traded entity to be called IntelliPharmaCeutics International Ltd. IPC is a privately-held specialty pharmaceutical company that is focused on developing and manufacturing new and generic controlled-release pharmaceutical products using its broadly applicable, proprietary delivery technologies...
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Par Pharmaceutical Companies, Inc. today announced that the U.S. District Court for the District of Delaware has ruled in favor of Par in its challenge of Purdue's patents relating to extended-release tramadol, which are listed in the Orange Book for Ortho-McNeil's Ultram ER product...
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Hospira Inc. stopped selling a generic chemotherapy drug just days after it got regulatory approval after the branded drug's maker, Sanofi-Aventis, went to court to block shipments...
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Eli Lilly and Company today announced that the U.S. District Court for the Eastern District of Michigan has granted a motion by Sun Pharmaceuticals for partial summary judgment. The Court's ruling invalidates Lilly's '826 patent, or method-of-use patent, for Gemzar(gemcitabine HCl for injection) which had been set to expire in 2013. The ruling has no bearing on Gemzar's compound patent, which remains valid until November 2010...
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Par Pharmaceutical Companies, Inc. today announced that its licensing partner, Aveva Drug Delivery Systems, has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for a clonidine transdermal system. Clonidine TDS is a generic version of Boehringer Ingelheim's Catapres TTS and is the first generic seven-day patch indicated in the treatment of hypertension...
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Mylan Inc. today announced that Matrix Laboratories, an Indian company in which Mylan owns a controlling stake, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for a fixed-dose combination (FDC) of Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Tablets, 600 mg/200 mg/300 mg. This is the first and only generic version of this product and will be eligible for purchase outside the U.S. in many developing countries....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of New Jersey has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's Singulair (Montelukast Sodium) Tablets, holding that U.S. Patent No. 5,565,473 is valid and enforceable....
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Medicis Pharmaceutical Corp. said it settled a lawsuit that alleged Sandoz, a unit of Novartis AG, infringed on a patent supporting Medicis' acne drug Solodyn ER....
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Mylan Inc. today announced that the company and its subsidiary Mylan Pharmaceuticals Inc. filed a civil lawsuit in the Circuit Court of Monongalia County, W.Va., against the Pittsburgh Post-Gazette, Post-Gazette reporters Len Boselovic and Patricia Sabatini, and others as yet unknown. ...
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Merck (MRK) received a favorable ruling in a major patent-infringement suit yesterday against the largest generic player, Teva Pharmaceuticals (TEVA), on its top-selling drug Singulair. Teva was seeking the Food and Drug Administration's (FDA) approval for selling a generic version of the drug for asthma and allergic rhinitis. The litigation has been continuing since Merck sued Teva in February 2007....
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A court order that briefly blocked Hospira Inc.' (HSP) approval to sell a generic version of the Sanofi-Aventis SA (SNY) colon-cancer drug Eloxatin in the U.S. has been dissolved, Hospira said Wednesday....
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The U.S. Patent and Trademark Office has ordered a re-examination of the patent for the blockbuster anti-clotting drug Plavix, citing new questions about the drug's patentability....
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German-based Bayer, the third largest pharmaceutical company in the world, has experienced something of a set back today after a court in India dismissed attempts to prevent regulators from approving a generic version of Bayer's Nexavar, the leading kidney and liver cancer drug....
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Back in 2007, Eli Lilly sued Sun Pharmaceuticals claiming that Sun's ANDA application filed in October 2006 infringed its patent on blockbuster cancer drug Gemzar. Today, Sun Pharma won a Gemzar patent motion against Eli Lilly....
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Teva Pharmaceutical Industries, the world's biggest generic drugmaker, could turn the tables on its Big Pharma rivals by snapping up Shire, a maker of branded specialty medicines...
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Simcere Pharmaceutical Group, a leading manufacturer and supplier of branded generic and innovative pharmaceuticals in China, today announced that forty-two of its generic drugs have been included in China's Essential Drug List, which was issued by China's Ministry of Health on August 18, 2009...
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A federal appeals court said Friday that it will reconsider its decision in April to toss out a $65 million ruling for Ariad Pharmaceuticals Inc. in a patent dispute with Eli Lilly & Co....
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Ranbaxy Laboratories Limited (RLL), announced today, that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Glycopyrrolate Tablets USP, 1 mg and 2 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Robinul 1 mg and Robinul Forte Tablets, 2 mg, respectively, of Sciele Pharma, Inc. The total annual market sales for Glycopyrrolate Tablets were $26 million. Glycopyrrolate Tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.
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Every year, people spend hundreds, sometimes thousands, of dollars on medication for their pets. And unlike the drugs they buy for their own use, these pet owners have a harder time finding lower-cost generic versions of drugs their vets prescribe for Fido or Tigger. In fact, 86 percent of pet drugs have no generic equivalent. So pet pharmaceutical companies, like Portland-based Putney, Inc., have been marketing human generic drugs for vets to prescribe. More recently, however, the company introduced its first generic drug approved for pets by the U.S. Food and Drug Administration. CEO Jean Hoffman spoke with Josie Huang about why Putney has branched out.
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US chemicals maker Cambrex will hope an FDA warning letter concerning its Italian manufacturing plant will not increase the pressure on its generic active pharmaceutical ingredients (API) business. ...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market 1% Clindamycin and 5% Benzoyl Peroxide Gel based on an agreement with licensing partner Dow Pharmaceutical Sciences, a subsidiary of Valeant Pharmaceuticals International. The preparation is the first generic version of Sanofi Aventis' BenzaClin to be approved by the U.S. Food and Drug Administration (FDA). ...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Levonorgestrel Tablets, 0.75 mg for over-the-counter use in women ages 17 and above, as well as for prescription use in women under the age of 17....
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Mylan Inc. today is pleased to announce that its subsidiary Matrix Laboratories Ltd. has been notified by the World Health Organization (WHO) Prequalification of Medicines Programme that the WHO has withdrawn its notice of concern for Matrix Unit 8, which is located in the Vizianagaram District of India, with no remaining concerns outstanding....
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