Generics Industry News Search
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April 2013 News Archive |
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India's top court dismissed Swiss drugmaker Novartis's attempt to win patent protection for its cancer drug Glivec, a blow to Western pharmaceutical firms targeting India to drive sales and a victory for local makers of cheap generics...
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Actavis, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone gel, 1.62%...
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Actavis, today confirmed that the United States District Court for the District of New Jersey has ruled that Actavis' generic version of AstraZeneca's Pulmicort Respules (Budesonide inhalation suspension) 0.25, 0.5 mg, and 1 mg vials do not infringe United States Patent No. 7,524,834 (the '834 Patent) and that United States Patent No. 6,598,603 (the '603 Patent) is invalid...
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A Delaware federal judge on Saturday handed a win to Cephalon in its patent infringement suit aiming to block the sale of generic versions of the narcolepsy drug Nuvigil, rejecting generic-drug makers' claims that Cephalon's patent on the drug was invalid...
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Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Acyclovir Ointment USP, 5%...
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Noven today confirmed that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market its Rivastigmine transdermal system in 4.6 mg/24 hours and 9.5 mg/24 hours dosage strengths...
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Valeant today announced that Valeant and Obagi Medical Products have executed an amendment to their agreement and plan of merger, dated March 19, 2013. Pursuant to the amendment, Valeant increased its offer to acquire Obagi from $19.75 to $24.00 per share in cash...
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Congressman Cory Gardner announced Friday that he will be introducing legislation to reauthorise the Animal Generic Drug User Fee Act, which supports the testing and review of generic animal drug applications by the Food and Drug Administration...
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Purdue on Tuesday widened its war against generic versions of insomnia drug Intermezzo, suing Dr. Reddy's in New Jersey federal court for alleged patent infringement in what is at least the sixth such complaint the company has launched...
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Dr. Reddy's Laboratories announced today that it has launched Zoledronic acid Injection (5 mg/100 mL), a therapeutic equivalent generic version of Reclast (Zoledronic acid) injection 5 mg/100 mL in the US market on April 03, 2013...
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Refusal to sell samples for bioequivalence testing violates antitrust laws, generics say...
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Actavis, and Valeant today announced that they have entered into an agreement, effective immediately, for Actavis to be the exclusive marketer and distributor of an authorised generic of Valeant's Zovirax ointment (Acyclovir 5%) product...
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India's Supreme Court is keeping the pressure on Western drugmakers...
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The US Patent & Trademark Office has issued Patent No. 8,372,826 to Synthetic Biologics...
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InnoPharma today announced the launch of Cidofovir injection (generic equivalent of Vistide) in 5mL single-use vials...
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The Federal Circuit on Monday found Cephalon's patent for narcolepsy medicine Provigil invalid and unenforceable, siding with Apotex's argument that Cephalon officials purposely didn't tell regulators another company had invented the drug...
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Dr Reddy's is being sued by US-based Purdue Pharma and Transcept Pharma over an alleged infringement of patents on anti-insomnia drug Intermezzo...
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Actavis and Valeant today announced that Actavis has reached settlement agreements with Medicis Pharmaceutical Corporation, a subsidiary of Valeant, resolving outstanding patent litigation related to Actavis' ANDA for Clindamycin and Tretinoin Gel, a generic version of Ziana, as well as Actavis' ANDA for Imiquimod Cream, a generic version of Zyclara...
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The stay is valid till May 13, when the main appeal against the revocation of patent would be heard...
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Bayer sued the U.S. Food and Drug Administration seeking to block sales of a generic form of the livestock antibiotic Baytril 100 being sold by competitor Norbrook...
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CVS Caremark focus on medication adherence saved PBM clients more than $643 million in 2012...
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Taro reported today that it has received approval from the U.S. Food and Drug Administration for its New Drug Application Topicort (Desoximetasone) topical spray, 0.25%...
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Drug major Lupin today said it has received US health regulator's approval for generic version of Teva branded's Seasonique tablets, used to prevent pregnancy, in the American market...
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Irish biopharmaceutical giant Shire lodged its latest bid Thursday to maintain patent protection over the blockbuster attention deficit hyperactivity disorder treatment Adderall XR...
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Sun announced that the US FDA has granted its subsidiary, two tentative approvals for its Abbreviated New Drug Applications for generic version of Januvia, Sitagliptin tablets and generic version of Glumetza, Metformin HCl extended-release tablets...
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For decades, pharmaceutical companies have deployed an array of tactics aimed at preventing low-cost copies of their drugs from entering the marketplace...
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Pfenex, a biotechnology company developing biosimilars and vaccines, and Agila Biotech, a subsidiary of Bangalore-based Strides Arcolab today announced that they have entered into a joint venture to develop, manufacture and commercialise an initial pipeline of six biosimilar products for the global market...
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Actavis today announced that it has re-launched Vestura (3 mg Drospirenone and 0.02 mg Ethinyl estradiol), a generic version of Bayer's Yaz oral contraceptive product, following a ruling from the United States Court of Appeals for the Federal Circuit that United States Patent No. RE 37,564 (the RE '564 Patent) is invalid...
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Spain and Italy lost a challenge at the European Union's highest court against the EU's decision to push ahead without them to create the bloc's first common patent system...
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In a major policy move, the Food and Drug Administration said Tuesday that it would not approve generic versions of the powerful narcotic OxyContin, the painkiller that symbolised a decade-long epidemic of prescription drug abuse...
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AbbVie, the drugmaker split off from Abbott this year, will fire its sales force for heart drugs as the medicines lose patent protection and face generic competition...
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Daiichi Sankyo and Ranbaxy today announced synergy in Brazil to expand the business of both companies in the country...
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Roche might face a reduced threat from one copycat competitor to its blockbuster Rituxan franchise...
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Cipla, one of India's leading generic pharmaceutical companies announces the launch of the first biosimilar of Etanercept in India; under the brand name Etacept for the treatment of rheumatic disorders...
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British antitrust authorities on Friday accused the pharmaceuticals giant GlaxoSmithKline of paying three rivals to delay the introduction of a generic version of an antidepressant drug. It is the latest so-called pay-for-delay case drawing scrutiny from regulators on both sides of the Atlantic...
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Extending patents and delaying the entry of generics is being taken seriously in Australia as the government moves to sue the patentee for causing a loss of millions of dollars to the publicly funded drug provider system...
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Pfizer on Friday hit Inventia with a suit in Illinois federal court, accusing its rival of infringing on its patents for extended-release bladder-control treatment Detrol LA with a planned generic version of the drug...
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South Africa plans to overhaul its intellectual property laws to improve access to cheaper medicines by making it harder for pharmaceutical firms to register and roll-over patents for drugs, a senior official said on Monday...
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An unusual legal challenge by one of the world's largest pharmaceutical companies could foreshadow a wave of lawsuits between makers of biologic medications, whose first patents will soon begin to expire, and the generic manufacturers who are planning to produce copycat versions of those drugs...
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Health Canada is facing increased criticism for its approval of generic Oxycodone after the US FDA decided to ban generic versions of the drug that has been widely abused across North America...
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Actavis today announced that is has reached a settlement agreement with Shire resolving outstanding patent litigation related to Actavis' generic version of Intuniv (Guanfacine hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder...
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No country has objected to India issuing compulsory licence or refusing patent for drugs says WTO chief Pascal Lamy...
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Actavis today announced that it has entered into an agreement with Purdue Pharma to settle all outstanding patent litigation related to Actavis' generic version of the currently marketed abuse-deterrent formulation of OxyContin...
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Federal regulators acted fairly when denying drugmaker AstraZeneca an extension to the exclusive rights to make an antischizophrenic drug, an appeals court said Friday...
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Aurobindo is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Cefadroxil for oral suspension USP, 250mg/5mL and 500mg/5mL (ANDA 065349)...
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Valeant and Actavis, two makers of generic drugs, have been in talks on a merger, people familiar with the matter said...
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Bayer won an agreement from the U.S. FDA to block sales of a generic form of the livestock antibiotic Baytril 100 made by Norbrook...
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Putney launches Enrofloxacin flavored tablets, the first and only available generic of Baytril taste tabs, the Company's fourth FDA approved veterinary generic medicine...
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Drugs giant GlaxoSmithKline has been accused by the competition watchdog of paying off firms to delay the launch of cheap versions of its antidepressant treatment in a move that denied the NHS "significant" cost savings...
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With a view to make Non-Hodgkin's Lymphoma (NHL) treatment cost-effective, Intas has successfully launched "Mabtas" in India...
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Acura, whose technology helps deter drug abuse, sued Ranbaxy, India's largest drugmaker, over its plan to market a generic version of the painkiller Oxecta...
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Aurobindo is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and Quinapril Tablets USP 5mg, 10mg, 20mg and 40mg (ANDA 202725)...
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