Generics Industry News Search
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January 2011 News Archive |
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Vietnam started yesterday selling Pegnano amid massive supports that the generic hepatitis drug is a lifesaver for the poor as well as protests from a Swiss firm that the act violates intellectual rights...
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Pharma company Lupin Ltd said that the company along with its subsidiary, Lupin Pharmaceuticals, Inc has settled all ongoing litigation over Lunesta (Eszopiclone) tablets, thereby dismissing a patent suit brought by the drug's manufacturer Dainippon Sumitomo Pharma Co, Ltd's subsidiary Sunovion Pharmaceuticals Inc...
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Aceto Corp., a Lake Success-based distributor of chemicals and generic drugs, has completed its purchase of a New Jersey pharmaceutical company, Aceto said Monday...
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Par Pharmaceutical Companies, Inc. today announced that it began shipping the 225mg, 325mg, and 425mg strengths of propafenone SR capsules, the generic version of GlaxoSmithKline's Rythmol SR...
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Par Pharmaceutical Companies, Inc. today announced that it began shipping all strengths of amlodipine besylate and benazepril hydrochloride capsules, the generic version of Novartis' Lotrel...
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After a three-year hearing, India's patent office has rejected an application filed by US drug multinational Abbott Laboratories for its anti-HIV drug Aluvia, a combination of the drugs lopinavir and ritonavir, according to a copy of the decision seen by Mint on Monday....
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A flurry of Accutane lawsuits will be going to trial this year in New Jersey state court, following an appeals court decision in August that reversed a $10.5 million verdict in one case and resulted in the delay of an Accutane trial involving three other cases...
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Labopharm Inc. today announced that, through its wholly owned subsidiary, Labopharm Europe Limited, it has monetized the expected future royalty payment stream for RYZOLT(TM) (once-daily tramadol)...
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Pfizer Inc has taken Dr. Reddy's Laboratories Ltd. to court in an effort to delay the launch of the Indian company's low-cost version of atorvastatin in the U.S., the Economic Times reported Tuesday...
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- Takeda Completes Settlements with 11 Generics, Finally Ending Actos Patent Dispute
- Lupin Settles Lunesta Patent Litigation with Sunovion
- AstraZeneca Denied Asserting Method Patents in Crestor Litigation...
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Sandoz today announced the introduction of two higher dosage strengths of amlodipine besylate/benazepril capsules, an authorized generic equivalent of Lotrel, which is currently marketed by Novartis Pharmaceuticals Corporation...
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Generic drug makers which include the likes of Mylan and Watson Pharmaceuticals have been on a bumpy ride lately, comments www.stockcall.com, an on-line South Africa-based research and analysis service....
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Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the research and development of mRNA and microRNA targeted therapies, and Pfizer Inc., today announced that the companies have expanded their collaboration directed to the development and commercialization of RNA-targeted medicines using Santaris Pharma A/S Locked Nucleic Acid (LNA) Drug Platform...
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CPEX Pharmaceuticals, Inc. announced today that it has entered into a definitive agreement with FCB I Holdings Inc., a newly formed company which is controlled by Footstar Corporation, under which FCB, through a wholly-owned subsidiary, will acquire all of the outstanding common stock of CPEX for $27.25 per share in cash...
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Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that it has signed a letter of agreement with Viropro, Inc., for the development of a biosimilar version of the monoclonal antibody drug rituximab (marketed by Genentech/Roche)...
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India's Natco Pharma has big plans for a Pfizer HIV drug--provided the world's largest drugmaker plays along...
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RPG Life Sciences, the pharmaceuticals and biotech arm of the RPG Group, today announced that it has commercialized its first indigenously developed and manufactured medicinal grade Ketoanalogue - Alfalog...
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India's Dr Reddy's Laboratories has told the country's leading newspaper it will challenge a US patent infringement suit filed against it by the world's number one pharmaceutical giant, Pfizer, last month...
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Teva Pharmaceutical Industries Ltd. announced today that it has completed the acquisition of Theramex, Merck KGaA's European-based women's health business...
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US drug maker Merck & Co has called off its association with Ranbaxy Laboratories that it had struck to develop anti-infective medicines, which could have fetched the Indian firm $100 million over a period of five years...
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Deutschpharmazie is now offering a larger selection of painkillers than every before...
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A U.S. District Court in Delaware today granted an injunction preventing Teva Pharmaceuticals USA, Inc., Teva Pharmaceuticals Industries Ltd., and Barr Laboratories, Inc. from commercializing generic versions of Amgen's Sensipar (cinacalcet) until expiration of the drug's U.S. patents...
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Pfizer Inc has sued Novartis AG's Sandoz unit, accusing it of infringing its U.S. patents related to the antifungal treatment Vfend...
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India's patent office has denied protection to Abbott Laboratories' AIDS drug Kaletra allowing generic drugmakers to continue selling their own versions of the drug, Bloomberg reported...
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A 30-month period stay of approval expires next week, marking the theoretical possibility of a launch of generic versions of Copaxone, Teva Pharmaceutical Industries Ltd's multiple sclerosis treatment...
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Members of Congress (Rep. Anna G. Eshoo, Rep. Jan Inslee, and Rep. Joe Barton) who sponsored the follow-on biologics portion of the comprehensive health care reform bill past year have sent a letter to the Food and Drug Administration, purportedly to explain the "legislative intent" of the data exclusivity provisions of the bill...
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Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration for Fentanyl Buccal tablets, USP, in the 0.1, 0.2, 0.4, 0.6 and 0.8 mg strengths, the generic equivalent to Cephalon's Fentora tablets...
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Elite Pharmaceuticals, Inc. and Hi-Tech Pharmacal Co., Inc. today announced that they have entered into an agreement for Elite to develop for Hi-Tech an intermediate for a generic version of a prescription product for which the branded product had sales in 2010 of over $100 million...
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Ordinarily, a patent is valuable when it offers some degree of market exclusivity. Over the past decade, we have seen a number of examples where a patent holder felt it necessary to take some additional steps to secure a term of exclusivity - namely paying would-be competitors to (1) not enter the market; (2) not challenge the patent's validity, enforceability, or scope; and/or (3) delay market entry...
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Sandoz announced today that it has begun a phase II clinical trial in patients for biosimilar rituximab (Roche's Rituxan/ Mabthera), a leading monoclonal antibody indicated in conditions including non-Hodgkin's lymphoma and rheumatoid arthritis...
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Generic drug-maker Aurobindo Pharma may settle a patent infringement dispute with US-based Wyeth Pharmaceutical out of court, sources close to the development said today...
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Last Friday, 32 State Attorneys General filed an amicus brief with the U.S. Supreme Court asking the Court to grant the Petition for Writ of Certiorari filed last month by a group of drug purchasers in Louisiana Wholesale Drug Co., Inc., et al., v. Bayer AG, et al...
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The Indian Patent Office lately revoked the Patent Number IN212199 issued to Novartis claiming single-pill combination of aliskiren and valsartan marketed as Valturna...
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Eli Lilly will pay Boehringer Ingelheim $387.4 million and collaborate with the German drugmaker to develop diabetes drugs with the U.S. pharmaceutical company facing the expiration of some of its key patents...
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Aurobindo Pharma Ltd is pleased to announce that it has entered into a definitive agreement with China National Pharmaceutical Group Corporation (Sinopharm) to divest in its subsidiary company Aurobindo (Datong) Bio Pharma Co Ltd, China (ADBPL), subject to regulatory approvals...
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Sanofi-aventis announced today that the European Commission has cleared sanofi-aventis' proposed acquisition of Genzyme Corporation unconditionally under EU merger control rules...
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Merck and PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced that they have entered into an alliance by which PAREXEL will provide strategic access to global clinical development services for designated biosimilar candidates to Merck BioVentures. Merck BioVentures, a division of Merck, is focused on the delivery of high quality biosimilars to the patients that need them...
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Watson Pharmaceuticals Inc. will begin selling a generic version of Pfizer Inc.'s blockbuster heart drug Lipitor in November and hopes to find itself alone in that lucrative market...
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Glenmark generics, U.S subsidiary of Glenmark Pharmaceuticals received final approval from USFDA for Abbreviated New Drug Application for generic version of Atovaquone & Proguanil Hydrochloride tablets in the strengths of 250 mg and 100 mg...
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GlaxoSmithKline L.L.C., which has operations in Philadelphia, sued generic drugmakers Anchen Pharmaceuticals Inc. and Banner Pharmacaps Inc. in federal court in Delaware, alleging infringement of patents for Avodart...
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Brand-name drug companies are fighting to weaken a provision of the health overhaul that was designed to open up generic competition in biotechnology medicines and save billions of dollars...
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Aspen, South Africa's leading pharmaceutical company, has announced that all conditions precedent have been met for it to acquire the pharmaceutical business of Australian-based Sigma Pharmaceuticals Limited...
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Drug firm Lupin on Friday said it has received final approval from US health regulator to market Nabumetone tablets, used in treating arthritis, in the American market...
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Drug and medical device maker Abbott Laboratories said it withdrew its request for U.S. and European approval of the potential psoriasis drug briakinumab...
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Sanofi-Aventis SA and Abbott Laboratories won a U.S. jury trial in which the drugmakers sought to halt Glenmark Pharmaceuticals Ltd.'s sales of a generic version of their hypertension medicine Tarka. Abbott was awarded $16 million in damages...
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About Court Report: Each week we will report briefly on recently filed biotech and pharma cases...
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Bayer AG was among drug firms told by European Union antitrust officials to submit details of patent-settlement deals that may be used to delay the sale of generic versions of medicines...
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Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug's patents expire, under a recent court decision...
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The United Nations has been enjoined in a case challenging the Government's decision to ban generic drugs for HIV and Aids...
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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 Acarbose Tablets, 25 mg, 50 mg and 100 mg, the generic version of Bayer's Precose Tablets, a treatment to be used with diet and exercise to improve glycemic control in adults with type 2 diabetes....
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The at-risk launch of the generic form of Tarka, an ACE inhibitor to control hypertension, by Glenmark Pharmaceuticals may get riskier, if the unfavourable verdict of the US federal jury is any indicator....
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In a further crackdown on anti-competitive practices, the European Commission has addressed information requests to selected pharmaceutical companies, asking them to submit copies of their patent settlement agreements - also dubbed pay-for-delay deals - concluded in the European Economic Area (EEA) in 2010 between originator and generic companies...
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The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan...
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Paddock Laboratories, Inc. is pleased to announce the addition of Opium Tincture, USP (Deodorized) C-II to our growing product line...
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Impax Laboratories, Inc.today commented on inaccurate and misleading information about its generic product pipeline that appears in several financial articles circulated on numerous financial websites...
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Depomed, Inc. today announced that it will engage in a mediation process with Abbott Products, Inc., regarding Abbott's commercialization obligations related to DM-1796, an investigational, once-daily formulation of gabapentin for the management of post-herpetic neuralgia...
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Merck will vigorously defend itself in a jury trial set to begin today in the Superior Court for Atlantic County, New Jersey...
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The following is a statement by Jim Keon, President of the Canadian Generic Pharmaceutical Association, regarding the report on intellectual property in the pharmaceutical sector released today by the Canadian Chamber of Commerce...
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Canada risks losing out on the next wave of lucrative pharmaceutical investment and jobs unless it matches tougher patent protection for drug makers in the U.S. and Europe, says a new report for the Canadian Chamber of Commerce...
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Today, Novo Nordisk announced that Judge Avern Cohn of the US District Court for the Eastern District of Michigan issued an adverse ruling in a patent litigation case regarding Novo Nordisk's US Patent No. 6,677,358...
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Pernix Therapeutics Holdings, Inc. and ParaPRO, LLC announced today that the U.S. Food and Drug Administration has approved Natroba (spinosad) Topical Suspension, 0.9% to eliminate head lice (pediculosis capitis)...
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Dr. Reddy's Laboratories today announced that it has launched Pantoprazole Sodium Delayed-Released tablets (20mg and 40mg strengths), a bioequivalent generic version of Protonix Tablets in the US market...
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The European Union Commission is on the lookout for "potentially problematic patent settlements" and has asked several pharmaceutical companies to submit copies of their patent-settlement agreements made between originator and generic-drug companies...
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Pfizer Inc., Merck & Co. and 35 other pharmaceutical companies have asked a federal judge to block the release of confidential documents detailing drug-patent litigation settlements, which Cephalon Inc. has requested as part of an antitrust dispute with the government...
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Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its New Drug Application for Lamivudine and Zidovudine Tablets, 30 mg/60 mg...
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Labopharm Inc. today announced that Health Canada's Therapeutic Products Directorate has approved OLEPTRO (trazodone hydrochloride Extended Release Tablets), a novel once-daily formulation of the antidepressant trazodone, for the symptomatic relief of Major Depressive Disorder in adults...
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Perrigo Co., a maker of over-the- counter drugs and infant formulas, agreed to buy the assets of closely held Paddock Laboratories Inc. for $540 million in cash to expand in generic medicines...
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Drug firm Wockhardt today said it has received final approval from the US health regulator -- US Food and Drug Administration to market generic pantoprazole tablets, used for treating ulcers and hyperacidity, in the American market...
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Caraco Pharmaceutical Laboratories has received some good news from a federal judge in Detroit that could pave the way for the company to market a generic version of the type 2 diabetes drug Prandin...
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AstraZeneca announced today it has replied to the US Food and Drug Administration's Complete Response Letter received for the ticagrelor (BRILINTA) New Drug Application on 16 December 2010...
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Daiichi Sankyo Company, Limited today announced that it has received approval in Japan to manufacture and market Memary 5mg, 10mg and 20mg Tablets (generic name: Memantine Hydrochloride) given once daily for the treatment of moderate to severe Alzheimer's Disease...
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GlaxoSmithKline and Valeant Pharmaceuticals International, Inc. announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion, recommending marketing authorisation for Trobalt (retigabine) as an adjunctive (add-on) treatment of partial onset seizures, with or without secondary generalisation in adults aged 18 years and above with epilepsy...
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Pfizer Inc. today announced that its wholly-owned subsidiary, Parker Tennessee Corp., has extended the expiration date of its tender offer for all outstanding shares of common stock of King Pharmaceuticals, Inc. for $14.25 per share, net to the seller in cash, without interest thereon and subject to any required withholding taxes...
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Biogen Idec announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a negative opinion recommending against approval of FAMPYRA (prolonged-release fampridine 10 mg tablets) to improve walking ability in adult patients with multiple sclerosis in the European Union...
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European regulators dealt Merck KGaA another blow by sticking with their recommendation against what once was the group's biggest pipeline hope, multiple sclerosis pill cladribine...
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BioDelivery Sciences International, Inc. today responded to a process patent infringement lawsuit filed and recently served against the Company and certain co-defendants by MonoSol Rx, LLC...
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Drugmaker Watson Pharmaceuticals Inc. said Friday it expects 2011 global revenue to climb in both its generic and branded segments, following a year in which net revenue grew 25 percent...
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The U.S. Food and Drug Administration approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults...
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Israel's Teva Pharmaceutical Industries has launched a High Court action in London to revoke the European patent for Seroquel, an anti-depressant developed by AstraZeneca, the Sunday Times reported...
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Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Pantoprazole Sodium Delayed-release Tablets USP, 20 mg (base) and 40 mg (base), the generic version of Wyeth's Protonix DR Tablets, a treatment for the irritation of the esophagus caused by gastroesophageal reflux disease...
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Orion Corporation has filed a patent infringement lawsuit in the United States to enforce Orion's U.S. patent No. 5,446,194 covering Comtan against Mylan Pharmaceuticals Inc...
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Natco Pharma plans to seek a compulsory licence from the government to make Bayer AG's Nexavar in India, invoking a provision in local laws that allows generic drugmakers to make and sell patented drugs cheaply if the medicine is unaffordable...
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Novartis announced today that it has entered into a definitive agreement for the acquisition of Genoptix, Inc., a specialized laboratory providing personalized diagnostic services to community-based hematologists and oncologists...
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Farmsintez, one of Russia’s leading pharmaceutical companies, has acquired Kevelt AS, an Estonian pharmaceutical manufacturer, which specializes in the contract manufacturing of finished drugs for certain European and US pharmaceutical companies, as well as solutions for the cryopreservation of stem cells...
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Swiss drug maker Novartis AG said it is paying $470 million to acquire U.S. cancer diagnostic specialist Genoptix Inc...
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Mylan Inc. today announced that it has entered into a settlement agreement with Pfizer Inc. resolving litigation related to Caduet Tablets, 2.5 mg/10, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg, known generically as Amlodipine Besylate/Atorvastatin Calcium Tablets...
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Mylan Inc. today announced that it has entered into a settlement agreement with Pfizer Inc. which will resolve litigation related to Lipitor Tablets, 10 mg, 20 mg, 40 mg and 80 mg, known generically as Atorvastatin Calcium Tablets. The terms of the agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission...
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The day when Teva Pharmaceutical Industries Ltd. will be allowed to market its generic version of anticoagulant Lovenox is nearing. The company yesterday received a US Food and Drug Administration Minor Deficiency letter, requesting its responses to questions from the review process. The letter indicates that the FDA has nearly completed its review of Teva's Abbreviated New Drug Application...
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A federal appeals court has rejected an argument by a generic drug manufacturer that it should be immune from liability through product liability lawsuits simply because they are copying the brand name medication and the FDA approved their product...
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FDA granted Bristol-Myers Squibb and Sanofi-Aventis a boon: The companies nailed down pediatric exclusivity for their megablockbuster blood thinner Plavix. That means six extra months of sales unhindered by generic competition. Plavix's FDA exclusivity is now set to end on May 17, 2012, while patent protection expires later this year
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Genmed Holding Corp. is preparing to apply for a marketing and distribution license within the country of Spain for the generic drug Paracetamol, otherwise known as Acetaminophen...
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