Generics Industry News Search
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August 2008 News Archive |
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Ranbaxy Laboratories Limited announced that the World Health Organisation (WHO), Geneva, has approved and included another of the company's anti retrovirals (ARV) drug in its pre-qualification list. The product approved by WHO, Geneva, Abacavir 300 mg tablets, will be manufactured at Ranbaxy's WHO pre-qualified manufacturing site at Paonta Sahib, India.
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it has received approvals from the U.S. Food and Drug Administration of its Abbreviated New Drug Applications for Doxycycline Tablets, 75 mg and 150 mg, the generic equivalent of Adoxa marketed by Par Pharmaceutical, Inc....
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Actavis Totowa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey facility....
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Japanese drug major Daiichi Sankyo today deferred its proposed open offer to acquire an additional 20 per cent stake in Ranbaxy Laboratories, citing a delay in approvals from market regulator Securities & Exchange Board of India (Sebi).
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KV Pharmaceutical filed an ANDA for a generic version of Ritalin LA (methylphenidate HCl extended-release capsules) with paragraph IV certifications to Celgene's U.S. Patent Nos. 5,837,284 and 6,635,284....
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Mexican President Felipe Calderon on Sunday at the opening ceremony of the XVII International AIDS Conference in Mexico City announced that he would lift restrictions on foreign pharmaceutical companies to allow them to produce and sell generic antiretroviral drugs in Mexico, NPR's "Morning Edition" reports.
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MonoSol Rx, a specialty pharmaceutical company leveraging its proprietary drug delivery technology to develop thin film pharmaceutical products, today announced the completion of pilot product development for its thin film formulation of escitalopram oxalate, a selective serotonin reuptake inhibitor....
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Mylan Pharmaceuticals has received final FDA approval for generic versions of Sciele Pharma’s anti-hypertensive Sular extended release (ER) in 20-, 30- and 40-mg strengths.
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Bayer AG said it has filed a patent infringement lawsuit to prevent Novartis AG's generic drugs unit Sandoz from selling a copycat version of the German group's oral contraceptive YAZ in the United States....
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Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Alendronate Sodium Tablets USP 10mg, 35mg and 70mg....
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Salix Pharmaceuticals, which has seen sales of its best-selling drug hurt by competition from cheaper generics, disclosed that two more of its products may come under generic pressure....
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WASHINGTON - The pharmaceutical industry's main trade group spent more than $5 million lobbying the federal government in the second quarter, according to a recent disclosure form.
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Ranbaxy Laboratories today said that the open offer by the Japanese drug maker Daiichi Sankyo for acquiring an additional 20 per cent stake in it will commence on August 16.
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Novartis AG will sell a generic version of Sanofi-Aventis SA's Plavix blood-thinner at a discount of about 25 percent in Germany, it said on Wednesday.
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Cipher Pharmaceuticals Inc. today announced that it has entered into a definitive development, distribution and supply agreement with Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary of Ranbaxy Laboratories Limited, under which Cipher has granted RPI the exclusive right to market, sell and distribute CIP-Isotretinoin in the United States, its territories and possessions.
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Actavis welcomes the announcement that a pharmacy licence for azithromycin has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The successful application relates to the pharmacy licence for Clamelle Azithromycin 500mg Tablets....
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GPhA Annual Policy Conference Speakers to Address Generic Pharmaceutical Issues Facing the Industry, the Next President and the New Congress in 2009
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The FDA has approved the first generic versions of Abbott's Depakote delayed-release tablets, 125, 250 and 500 mg.
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The efforts of Indian biotech firms, which are keen to enter the global biogenerics (copycat version of biotech drugs) market, are boosted by a number of recent studies carried out by various companies and agencies....
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Andrew Bodnar, a former senior vice-president of Bristol-Myers Squibb, has been indicted for his role in lying to the federal government about a patent deal involving the popular blood-thinning drug, Plavix, used by heart attack and stroke survivors and other patients....
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that one lot of 75 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies. ...
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Indian drugmaker Dr. Reddy's Laboratories Ltd has received approval from the U.S. Federal Drug Administration to make and market alendronate sodium tablets....
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Q: I'm a 48-year-old woman. I found out four years ago that I have thyroid disease. I've been taking Synthroid, but recently my husband lost his job, and with it our health insurance. I've been off the medication now for a month. What will happen if I'm unable to take Synthroid because I cannot afford it anymore? Is there a substitute that I can take until my husband finds a job?...
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Brazil, one of the major emerging powers of the world, is marking its presence in almost every dimension of the world economy, including the generic drugs industry. ...
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Pfizer Inc. said it has agreed to settle litigation related to its cholestrol drug Lipitor with Canadian generic drug maker Apotex Inc.
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Sanofi-Aventis, France's largest drugmaker, sued Canada's Apotex Inc. claiming infringement of two U.S. patents for the cancer drug docetaxel.
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Barr Pharmaceuticals, Inc. announced today that its Barr Laboratories subsidiary has signed a Settlement Agreement and a License Agreement with Boehringer Ingelheim to resolve the patent litigation involving Boehringer Ingelheim's Mirapex product. Separately, Barr Laboratories entered into a Settlement Agreement and a Supply Agreement to resolve the patent litigation regarding Boehringer Ingelheim's Aggrenox
product and Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, entered into a Co-Promotion Agreement with Boehringer Ingelheim relating to Aggrenox.
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KV Pharmaceutical Company a fully integrated specialty pharmaceutical company, today announced a significant expansion of its commercial collaboration with Australian drug delivery company Acrux, under which KV will incorporate Acrux's unique spray technology for delivering drugs through the skin in up to six additional new branded products to be designated by KV for future development.
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Teva Pharmaceuticals is pleased to announce the introduction and availability of Doxycycline for Oral Suspension USP....
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The Food and Drug Administration approved 18 generic drugs made by Ranbaxy Laboratories Ltd. even as the U.S. investigated whether the company fabricated data to get its medicines cleared.
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the United States District Court for the Southern District of Florida ruled today that Watson's Naproxen Sodium ER tablets, the generic version of Naprelan, infringes Elan's U.S. Patent....
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IMPAX Laboratories, Inc. today announced Purdue Pharma Products L.P., Napp Pharmaceutical Group Ltd., Biovail Laboratories International, SRL and Ortho-McNeil, Inc. have filed suit for patent infringement in the United States District Court for the District of Delaware...
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Filed August 13, 2008 in the District Court of Delaware Infringement of U.S. Patent, "Method of treating Alzheimer's disease. ...
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Sun Pharmaceutical Industries Ltd. today announced that on August 13, 2008, the U.S. Federal Trade Commission granted early termination of the antitrust waiting period under the Hart-Scott-Rodino Act for the previously announced Tender Offer by Alkaloida Chemical Company Exclusive Group Ltd., a subsidiary of Sun Pharma....
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The Generic Animal Drug Alliance today announced that President Bush signed into law the Animal Generic Drug User Fee Act of 2008. Under the Animal Generic Drug User Fee Act, generic animal health companies for the first time will pay user fees to provide essential resources to improve generic animal drug review times-getting high quality, affordable generics to veterinarians, and animal and pet owners, faster.
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it will immediately begin offering bulk packs of certain products it manufactures....
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Teva is eyeing Germany's third largest generics company even before completing the acquisition of Barr.
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Abbott and AstraZeneca announced today that they have entered into an agreement for Abbott to promote AstraZeneca's CRESTOR.
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With the threat of patent expiry looming ever nearer for a number of biopharmaceuticals, generic manufacturers are looking to seize the potentially great commercial rewards in this unexploited territory. It is predicted that by 2010 nearly 50 per cent of all new approved pharmaceuticals will be biopharmaceuticals and that $60 billion worth of biopharmaceuticals will be going off patent in the next few years. ...
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Actavis has received approval from the US Food & Drug Administration to market Bupropion Hydrochloride extended-release tablets 300mg. Distribution of the product will commence immediately.
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Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration. ...
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Hyderabad-based Natco Pharma Ltd, after trying its hand at plain vanilla generic products, is now set to move to the next level by focusing on technology as well as on drug retailing.
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CEL-SCI Corporation announced today that it has entered into an exclusive licensing agreement with Teva Pharmaceutical Industries Ltd....
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Barr Pharmaceuticals, Inc. today announced that its subsidiary, PLIVA - Lachema a.s., has received final approval from the U.S. Food and Drug Administration for its generic version of Pfizer Inc.'s Aredia Injection....
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A U.S. appeals court upheld an infringement finding against generic drug makers Apotex and Impax on Wednesday in a case brought by AstraZeneca to defend the patents for its popular heartburn drug Prilosec.
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A U.S. judge ruled in favor of shareholders suing Bristol-Myers Squibb about its disclosures while settling patent litigation with Canadian generic drug maker Apotex Inc over the blood-thinner Plavix....
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Indian drug maker Lupin Ltd said on Thursday it had bought a stake in Australian firm Generic Health for an undisclosed sum....
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Global pharmaceutical giant Pfizer's domestic market share of its top seller Lipitor slipped nearly 15 percent in just one month after local drugmakers released generics of the cholesterol-lowering pill in June. But the head of the Korean operation isn't sweating over it....
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Health Minister Chaiya Sasomsap said that the government of Thailand will override the patents on three cancer drugs, after pressure from health activists and doctors calling on him to resign. Over the course of five years, the decision is expected to save the government of Thailand, and cost the pharmaceutical companies, more than 3 billion baht ($100 million).
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Raghavendra Rao, MD of Orchid Chemicals expects around USD 100 million from the launch of the new products next year. The are expecting only one-two players in the field so there will be limited competition with respect to Tazobactam-Pipperacillin in the US.
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The offer period is underway for Japanese drugmaker Daiichi Sankyo's bid for Ranbaxy laboratories - India's largest drug firm by sales. Daiichi plans to acquire 20% of the firm in the open market, with private deals making up the rest of its eventual majority stake. The offer forms part of a trend in which established drugs firms deal with the threat of developing-world generics firms by buying, or copying, them. ...
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Aurobindo Pharma, a Hyderabad-based drug firm, can now tap the fast-growing anti-hypertensive segment in the US as it has received a tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market losartan potassium tablets in the US. ...
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The Opposition Division of the Patent Office in New Delhi has allowed the opposition of an Indian patent organisation against Boehringer Ingelheim's patent application for the suspension form of an HIV/AIDS drug nevirapine (trade name VIRAMUNE). According to Indian law, this decision can be contested in the Indian courts....
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More pharma M&A; action today, with King Pharmaceuticals announcing that Alpharma rejected a $1.4 billion cash buyout offer King made earlier this month. Alpharma's decision to walk away from the offer - and the market's reaction to today's news - is yet another sign of the strong position held by small drug companies with products on the market....
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The patent dispute concerned generic market entry in competition with Merck's branded Trusopt and Cosopt glaucoma medications. ...
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Baxter Healthcare Corporation today announced a licensing agreement with Innocoll Pharmaceuticals Ltd, granting Baxter exclusive rights to market and distribute the company's gentamicin surgical implant in the United States....
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Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Azur Pharma International in connection with its FazaClo(clozapine) orally disintegrating tablets, 25mg and 100mg....
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Astelin (azelastine hydrochloride nasal spray) is used for treatment of allergic and non-allergic rhinitis. The product is protected in the U.S. by a patent that expires on 1 November 2010, with paediatric exclusivity extending until 1 May 2011....
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Codexis, Inc and Arch Pharmalabs Limited, today announced a major new strategic collaboration, expanding their three-year partnership in pharmaceuticals manufacturing....
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Glenmark Pharmaceuticals, which separated its generics and new drug discovery businesses into two companies late last year, says it aims to grow on the lines of the $6.4-billion Swiss drug-maker Novartis....
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Japan's Daiichi Sankyo's proposal to acquire Ranbaxy will go to the Cabinet Committee on Economic Affairs (CCEA) for approval. Any foreign deal exceeding Rs 600 crore has to be approved by the CCEA under the existing policy.
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Drug developer Watson Pharmaceuticals Inc. spent $230,000 in the second quarter to lobby on generic drug issues, federal reimbursement on prescription drugs and proposals on a system for generic biotech drugs, according to a recent disclosure report....
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Teva Pharmaceutical Industries Ltd. announces that results of the phase III ADAGIO trial were presented today during the 12th Congress of European Federation of Neurological Societies in Madrid, Spain as part of a "Late Breaking News" session....
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Sun Pharmaceutical Industries Ltd. today announced it was victorious in all elements of its defense of the litigation brought against it in the Tel-Aviv District Court by Taro Pharmaceutical Industries Ltd. and certain of its directors....
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Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne (galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets....
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Teva Pharmaceutical Industries Ltd sued Swiss drugmaker Novartis AG and Momenta Pharmaceuticals Inc on Thursday, accusing them of infringing patents on its multiple sclerosis drug Copaxone.
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Hi-Tech Pharmacal Co., Inc. announced that the Company filed a complaint in the U.S. District Court for the District of Columbia against the U.S. Food and Drug Administration requesting a declaratory judgment related to Hi-Tech's Abbreviated New Drug Application for dorzolamide and timolol ophthalmic solution....
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Pfizer Inc said today that the Eastern Division of the High Court in Copenhagen, Denmark has ruled in the company's favor in challenges to two of its patents covering atorvastatin, the active ingredient in Lipitor. ...
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Dr. Reddy's Laboratories Ltd. has received final approval from the U.S. Food and Drug Administration to make and sell multiple strengths of generic Trandolapril tablets....
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Mylan Inc. today announced that its subsidiary Alphapharm Pty Limited won a favorable decision in patent litigation against it and Barr Laboratories Inc. relating to Galantamine Tablets, USP, the generic version of Ortho-McNeil's Razadyne Tablets, 4 mg, 8 mg and 12 mg....
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Gurgaon-based Ranbaxy Laboratories has emerged as the top pharmaceutical company, ahead of Cipla, in terms of market share in the Rs 36,000 crore domestic drug market for July....
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