Generics Industry News Search
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April 2011 News Archive |
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IntelliPharmaCeutics International announced the filing of an Abbreviated New Drug Application or ANDA with the U.S. Food and Drug Administration or FDA for a generic of Seroquel XR...
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Teva UK has announced the launch of a new generic version of Motens, Boehringer Ingelheim's treatment for hypertension....
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Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Takeda Pharmaceutical Company, Ltd. in connection with DEXILANT (dexlansoprazole) delayed-release capsules, 30 mg and 60 mg...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Latanoprost Ophthalmic Solution, 0.005%, the generic version of Pharmacia and Upjohn's Xalatan Ophthalmic Solution, an eyedrop that lowers pressure in the eye...
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Cubist Pharmaceuticals, Inc. today announced that it has entered into a license agreement with Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd., which includes a stipulation by the parties requesting dismissal of the lawsuit filed by Cubist in the U.S. District Court for the District of Delaware relating to the Abbreviated New Drug Application filed by TPM with the U.S. Food and Drug Administration for a generic version of CUBICIN (daptomycin for injection)...
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Mylan Inc. today announced that its subsidiary Bioniche Pharma has launched Octreotide Acetate Injection USP, pre-filled syringes, the generic version of Novartis' Sandostatin, a treatment for a rare hormonal disorder called acromegaly...
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Claims that Canada's proposed trade deal with the European Union would add C$2.8 billion a year to Canada's drug costs are based on flawed assumptions and should be ignored, research-based drugmakers have said...
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The pharmaceutical and biotechnology industries are gearing up for another round of debates on patent reform as the US House of Representatives begins consideration of proposed legislation...
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Merck and Inspire Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement under which Merck will acquire Inspire, a specialty pharmaceutical company focused on developing and commercializing ophthalmic products...
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SOHM, Inc.a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories announced today that the Company projects revenue growth of 200 percent in 2011...
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Shire plc, the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the Southern District of New York against Watson Pharmaceuticals, Inc. and its subsidiaries Watson Laboratories, Inc.-Florida, Watson Pharma, Inc., Andrx Corporation, and Andrx Pharmaceuticals, L.L.C. for infringement of Shire's U.S. Reissue Patent No. RE 41,148, U.S. Reissue Patent No. RE 42,096 and U.S. Patent No. 6,913,768 and also for breach of contract...
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Salix Pharmaceuticals, Ltd. today announced that as of March 31, 2011 Lupin Ltd. granted Salix exclusive worldwide rights (except for India) to exploit Lupin technology and technology jointly developed by Lupin and Salix for all rifaximin products for human use...
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Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, granted tentative approval for the Company's Abbreviated New Drug Application, for levofloxacin oral solution 25mg/mL, the generic for McNeil Pharmaceutical's Levaquin oral solution...
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Alcon, Inc. announced that its shareholders approved the merger of Alcon into Novartis AG at its Annual General Meeting of Shareholders...
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Meda has reached an agreement with Novartis to acquire global rights for Elidel (pimecrolimus 1% cream). Elidel is a patent protected, specialty focused product for the treatment of atopic dermatitis...
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Unichem laboratories Limited are pleased to announce that it has received ANDA approval from the United States Food and Drug Administration for Divalproex Sodium Delayed Release Tablets...
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Amgen, the world's largest biotechnology company, announced today the expansion of its operations in Brazil, including the acquisition of Bergamo, a privately-held Brazilian pharmaceutical company...
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Merck & Co., the second-biggest U.S. drug company, lost a U.K. court bid to reinstate its European patent for the glaucoma treatment Cosopt after a successful challenge by Teva Pharmaceutical Industries Ltd...
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Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, granted tentative approval for the Company's Abbreviated New Drug Application, for brimonidine tartrate with timolol maleate ophthalmic solution...
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Moxifloxacin Hydrochloride Ophthalmic Solution USP, 0.5%...
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Sanofi-aventis announced today that it has completed its acquisition of Genzyme Corporation, which is now a wholly-owned subsidiary of sanofi-aventis...
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Sandoz today announced the US Food and Drug Administration approval and US launch of Altavera (levonorgestrel and ethinyl estradiol tablets), a generic equivalent of Nordette...
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Cephalon Inc. won a court order that prevents generic-drug makers from selling low-cost versions of its muscle relaxant Amrix until a judge rules on a patent dispute over the drug...
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Impax Laboratories Inc. said Monday that it is challenging the patents on Purdue Pharma's painkiller Oxycontin in order to be able to sell a generic version of the drug...
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Merck & Co., Inc., a global health care leader, known as MSD outside the United States and Canada, and Sun Pharmaceutical Industries Ltd., a leading Indian multinational pharmaceutical company, today announced the creation of a joint venture to develop, manufacture and commercialize new combinations and formulations of innovative, branded generics in the Emerging Markets...
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Endo Pharmaceuticals and American Medical Systems announced today that they have entered into a definitive agreement under which Endo will acquire AMS, a leading provider of world-class devices and therapies for male and female pelvic health, for $30 per share, or $2.9 billion in cash, which includes the assumption and repayment of $312 million of AMS debt...
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About Court Report: Each week we will report briefly on recently filed biotech and pharma cases...
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Global pharma major Takeda Pharmaceutical has filed a patent infringement suit against India's second largest drug maker Dr Reddy's in a New York Court over the latter's efforts to manufacture a generic version of acid reflux treatment drug Dexilant (Dexlansoprazole)...
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Better late than never. Pharma giant Amgen has finally discovered Brazil with its $215 million acquisition of generic and over-the-counter drug lab Bergamo Ltda on April 8. The deal allows Amgen to regain rights to its cancer drug Vectibix in Brazil...
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A generic version of latanoprost ophthalmic solution 0.005% is now available following the FDA's final approval of Mylan Pharmaceutical's abbreviated new drug application for a former proprietary solution (Xalatan, Pfizer) to lower IOP in patients with ocular hypertension or glaucoma...
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Watson Pharmaceuticals, Inc. has terminated its supply and licensing agreements with Stellar Pharmaceuticals Inc related to Uracyst, a sodium chondroitin sulfate solution for the treatment of interstitial cystitis, a chronic pain condition that affects the bladder....
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Dr. Reddy's Laboratories announced today that it has launched its over-the-counter fexofenadine HCl tablets on April 13, 2011...
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Perrigo Company and Teva Pharmaceutical Industries Ltd. have obtained final OTC approval to sell a generic version of Sanofi-Aventis SA's Allegra allergy treatment...
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Genzyme Corp, a subsidiary of French Drug maker Sanofi-Aventis, has filed suit against two companies and their subsidiaries alleging patent infringement related to its Synvisc osteoarthritis product...
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Reckitt Benckiser Group Plc was given a final fine of 10.2 million pounds ($16.6 million) by a U.K. regulator for halting supplies of a heartburn medicine to the National Health Service to block sales of a generic version...
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Genzyme Corp, a subsidiary of French Drug maker Sanofi-Aventis, has filed suit against two companies and their subsidiaries alleging patent infringement related to its Synvisc osteoarthritis product...
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Merck, known as MSD outside the United States and Canada, and Johnson & Johnson and its subsidiary Centocor Ortho Biotech Inc., today announced that the companies have reached agreement to amend the distribution rights to REMICADE and SIMPONI, which treat chronic inflammatory diseases such as rheumatoid arthritis ...
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Pozen Inc., a pharmaceutical company committed to transforming medicine that transforms lives, announced today that the U.S. District Court for the Eastern District of Texas has granted a preliminary injunction ordering Par Pharmaceutical Inc. not to make, use, sell, offer to sell, or import into the United States a generic version of sumatriptan/naproxen sodium that competes with Treximet sold by GlaxoSmithKline in the United States under an exclusive license from the Company...
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The amendments to the Therapeutic Goods Regulations 1990 to create a new regulatory framework for biologicals were passed by Executive Council on 10 March 2011. The biologicals framework will commence on 31 May 2011. After this date, all products within the scope of the framework will need to comply with the requirements made under the new legislation, subject to relevant transition arrangements...
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Drug maker Lupin today said it is aiming to become one of the top five generic pharmaceutical companies in Japan in the next three years...
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The U.S. Food and Drug Administration is warning that a dissolvable generic heartburn drug made by Teva Pharmaceutical Industries Ltd. may clump and cause problems for patients using an oral syringe or feeding tube...
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Reckitt Benckiser is facing an 89 million lawsuit from the NHS after allegedly co-ordinating updates of GP prescription software so that the cheap version of its Gaviscon heartburn medicine no longer appeared...
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Shares of biopharmaceutical company ViroPharma Inc. fell Monday after the company said a U.S. District Court ruled against it in a challenge to an FDA decision...
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Aurobindo Pharma Limited is pleased to announce that its tentatively approved ANDA for Venlafaxine Hydrochloride Extended-release Capsules 37.5mg, 75mg and 150mg has received the final approval from the US Food & Drug Administration...
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Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Imiquimod Cream, 5%...
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Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration for marketing 37.5mg, 75mg and 150mg extended release capsules of Venlafaxine HCl, which is used for treatment of depression and anxiety disorders...
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Hyderabad-based Orchid Chemicals has reached an out-of-court settlement with world's largest drugmaker Pfizer Inc to sell a low-cost version of the American firm's patented anti-depressant drug, Effexor XR in the US market this fiscal...
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SciClone Pharmaceuticals, Inc. today announced that it has acquired NovaMed Pharmaceuticals Inc., a China-based specialty pharmaceutical company...
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Novartis AG, seller of the Lucentis blindness treatment, sued AstraZeneca's MedImmune unit and a U.K.-financed research agency in a bid to revoke an extension on patent protection for a drug manufacturing process...
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Genentech, a member of the Roche Group and Biogen Idec announced today that the U.S. Food and Drug Administration approved Rituxan (rituximab), in combination with corticosteroids, as a new medicine for adults with Wegener's Granulomatosis and Microscopic Polyangiitis...
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U.S. drug spending didn't just hit a growth slump last year. In another worrisome development for drugmakers, generics took every slot on the list of the 10 most-prescribed drugs compiled by IMS Healthcare Informatics; only three branded drugs made the entire ranking of 25, the Wall Street Journal Health Blog reports...
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Colesevelam HCI 625 mg tablets...
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Salix Pharmaceuticals, Ltd. today announced that the U.S. Patent and Trademark Office has issued three patents relating to rifaximin...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Famciclovir Tablets, 125 mg, 250 mg and 500 mg, the generic version of Novartis' Famvir Tablets, a treatment for herpes...
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Roche Holding AG's Genentech unit sued Sandoz Inc. for planning to sell a generic version of Valcyte, which treats a virus that afflicts transplant patients and people with AIDS, before Genentech's patent expires...
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Novartis AG, Europe's second-biggest drugmaker by sales, sued Teva Pharmaceutical Industries Ltd. in U.S. District Court alleging infringement of patents for Myfortic, used to help prevent organ rejection in kidney transplant patients...
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Dr. Reddy's Laboratories Ltd., India's second-largest drugmaker, will be allowed to sell a generic version of Wyeth's antidepressant drug starting June 1 following an agreement with the unit of Pfizer Inc...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Letrozole Tablets USP, 2.5 mg, under a previously announced settlement and license agreement with Novartis...
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Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food & Drug Administration for marketing 5mg and 10mg tablets of Donepezil HCl, which is used for treatment of Alzheimer's disease and dementia...
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POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, today announced that it and AstraZeneca filed a lawsuit against Dr. Reddy's Laboratories in the United States District Court for the District of New Jersey, for infringement of U.S. Patent No. 6,926,907 relating to VIMOVO delayed-release tablets...
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Sandoz Inc has reportedly said that it has filed a plea with the U.S. Food and Drug Administration seeking to sell a generic version of AzaSite...
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Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration to manufacture and market Divalproex Sodium Delayed - Release Tablets USP 125mg, 250mg and 500mg...
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Ranbaxy Laboratories Limited today announced the Day-1 launch of Olanzapine Tablets, the generic version of Zyprexa...
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India's Lupin Ltd. said Tuesday it and its units have agreed to buy licenses from U.S.-based Abbott Laboratories and France's Laboratoires Fournier S.A. for various patents on anti-cholesterol drug fenofibrate in an attempt to ring fence its Antara brand from generic competition...
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Drug maker Lupin announced their generic Metformin Hydrochloride was tentatively approved by the US Food and Drug Administration to help treat diabetes...
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A shortage of stimulants to treat ADHD 'attention deficit hyperactivity disorder' has forced some Minnesota patients to pay more for expensive brand name medications or make a frustrating switch to short acting versions of their drugs, according to local physicians....
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GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article that analyses opportunities in launching generic versions of Quetiapine....
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American drugmaker Purdue Pharma has sued Ranbaxy Laboratories to prevent India's largest drugmaker from selling a generic or low-priced version of its bestselling medicine, pain reliever Oxycontin, in the US...
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Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food & Drug Administration (US FDA) for marketing 5mg and 10mg tablets of Donepezil HCl, which is used for treatment of Alzheimer's disease and dementia. Donepezil is the generic name for the brand Aricept, marketed in the United States by Eisai in partnership with Pfizer. Wockhardt will be launching the product in the US market on May 28, 2011. According to IMS Health, the total market for this product in the US is about $2.5B...
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Eli Lilly and Company today announced that the U.S. District Court for the Southern District of Indiana has issued an order that prohibits the remaining defendants in the Cymbalta patent litigation from selling a generic duloxetine product in the United States during the term of the Cymbalta compound patent....
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Cambridge, MA-based biotech Genzyme, now a unit of Sanofi-Aventis, has amended its patent infringement lawsuit against its competitor Anika Therapeutics related to Anika's osteoarthritis treatment, Monovisc...
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The European Commission has opened a formal antitrust investigation to assess whether an agreement between US-based pharmaceutical company Cephalon and Israel-based generic drugs firm Teva may have had the object or effect of hindering the entry of generic Modafinil in the European Economic Area...
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A federal judge will decide early next week whether to end Mylan Inc.'s legal maneuvering aimed at improving the chance it could sell a generic version of Pfizer Inc.'s blockbuster cholesterol-lowering drug Lipitor as early as June...
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Healthcare costs have been rising faster than overall prices, but some prescription-drug relief is on the way. Over the next few years, an abnormally large number of blockbuster drugs are scheduled to lose their patent protection, opening the doors to cheaper generic drugs...
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