Generics Industry News Search
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October 2013 News Archive |
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Lundbeck and Takeda won approval for the drug Brintellix to treat people with major depressive disorder, U.S. regulators said...
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Teva announces the launch of the generic equivalent to Zemplar (Paricalcitol) tablets in the United States as of September 30, 2013...
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Generic drug manufacturing companies are always looking for patent expirations of other companies' blockbuster drugs...
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AstraZeneca today announced that the US Court of Appeals for the Federal Circuit (CAFC) lifted a temporary injunction against the US launch of Hanmi's 505(b)2 NDA Esomeprazole strontium product...
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Lupin Pharmaceuticals, the US subsidiary of pharmaceutical major, Lupin Limited, announced today that it has launched its generic Gatifloxacin Ophthalmic Solution, 0.5%...
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Teva Pharmaceutical announced that the District Court of the Hague (Netherlands) has issued a favourable ruling in a patent revocation action brought by Mylan B.V., a subsidiary of Mylan Laboratories, seeking a court judgment that Teva's European Patent (NL) 762,888 expiring May 2015 for its relapsing-remitting multiple sclerosis (RRMS) product, Copaxone (glatiramer acetate injection) is invalid...
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Hospira is recalling one lot of generic Reglan and two lots of generic Zofran, after injectable versions of the drugs were found to contain strands of glass...
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Par today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Clonidine hydrochloride 0.1 mg extended-release tablets...
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Elite announced today the signing of a Manufacturing and License Agreement with Epic...
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Actavis today confirmed that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride sublingual film 2 mg/0.5 mg and 8 mg/2 mg...
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The cautious comments by the world's biggest maker of generic medicines during an investor presentation on Tuesday is good news for GSK shareholders, who had feared cheaper forms of the $8 billion-a-year seller might come around two years sooner...
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Lannett said Tuesday it has cleared a key hurdle in its effort to sell generic Thalidomide capsules...
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Acura, a specialty pharmaceutical company developing products intended to address medication abuse and misuse, announced today that it has entered into distinct Settlement Agreements with each of Par and Impax, to settle Acura's patent infringement action pending against them in the United States District Court for the District of Delaware...
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The world's largest maker of generic drugs by sales said it expects its overall cost-cutting programme to save about $2 billion a year by the end of 2017...
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Gov. Jerry Brown has vetoed a bill that critics said would have hindered the use of cheaper versions of high-priced biotechnology drugs, providing a victory for health plans and generic drug companies over brand-name pharmaceutical manufacturers...
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German drug major Bayer has challenged the Intellectual Property Appellate Board's order of compulsory licence issued to domestic pharmaceutical company Natco in the Bombay High Court and has sought the court's intervention to protect its rights over patented cancer drug Nexavar...
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Teva announces today that the U.S. Food and Drug Administration has granted approval of the generic equivalent to Tobi (Tobramycin) in the United States...
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The US Food and Drug Administration on Friday quietly announced that a second generic version of Wellbutrin XL 300 mg, a popular antidepressant manufactured by GlaxoSmithKline, has been found to not be bioequivalent to the drug and will be pulled off the market...
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The U.S. District Court for the Western District of Texas has entered a consent judgment, ruling that PureTek's RE OB+DHA and PNV OB +DHA prenatal vitamins infringe on San Antonio-based Mission Pharmacal's '247 patent...
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A recent European Union regulation on customs enforcement of intellectual property rights has raised concerns among civil society actors who find that the regulation might not be an improvement over its previous version under which seizure of legal generic medicines in transit occurred a few years ago, leading to a World Trade Organisation dispute...
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Prasco announced today it has signed an exclusive distribution and supply agreement with Shire for the authorised generic of Fosrenol (Lanthanum carbonate) chewable tablets...
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The Academy of Managed Care Pharmacy today established a biosimilars task force to begin developing a biosimilars collective intelligence system to document their safety and efficacy, using continuous analysis of available data for innovator specialty drugs as reference points...
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Jubilant announced today that it has received Abbreviated New Drug Application approvals from the US Food and Drug Administration for Bupropion hydrochloride extended-release tablets...
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Nephron has recalled 10 lots of Albuterol for nebulisers because of possible problems with aseptic processing, according to a company release posted on the FDA website...
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The new facility at the production site in Zagreb will considerably increase Pliva's production capacities for tablets and capsules and directly increase exports as the majority of these products are intended for international markets...
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Jim Keon, President of the Canadian Generic Pharmaceutical Association, issued the following statement regarding today's announcement by Prime Minister Harper and President Barroso of an Agreement in Principle in the negotiations for a Comprehensive Economic and Trade Agreement...
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Stada strengthens business activities in Russia with the signing of a contract for the purchase of the branded product portfolio Aqualor for the self-medication of sinusitis and sore throat...
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Health Minister Rona Ambrose suggested Monday there could soon be movement from Canada on U.S. pleas to outlaw addictive, generic formulations of the painkiller OxyContin amid a simmering dispute between the two countries...
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Heritage announced the immediate availability of Tetracycline HCl Capsules, USP in 250 and 500 mg strengths...
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Baxter on Tuesday hit HQ Specialty Pharma Corp. with a lawsuit in New Jersey federal court alleging HQ's proposed generic version of its blood pressure and heart rhythm disorder drug Brevibloc infringes two of its patents: U.S. Patent Numbers 6,310,094 and 6,528,540...
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Takeda accused generic-drug manufacturer Amneal of infringing its patents for a gout medication in Delaware federal court Monday, adding to Takeda's growing legal battles over the drug...
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Brazil's rapidly growing drug market, fueled by an aggressive government plan to boost healthcare spending, is spurring new production facilities, but not just from the Western drugmakers...
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Orygen will develop, manufacture, and commercialize several products of Epirus in Brazil, starting with a biosimilar version of the arthritis drug Remicade (Infliximab), in a deal worth up to $275 million, the companies said today...
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Hospira, the world's leading provider of injectable drugs and infusion technologies, said at the WHO today that biosimilar drugs should be given the same nonproprietary names as original biologics to ensure patient access and safe prescribing...
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Ono announced today that it has entered into a license agreement with Valeant to exclusively develop and commercialise Metyrosine in Japan, which is currently being manufactured and marketed in the United States for the treatment of pheochromocytoma...
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Unichem today said it has received approval from the US health regulator USFDA for its generic Amlodipine besylate tablets used for treating hypertension and coronary artery disease...
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Impax today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Atelvia (Risedronate sodium) delayed-release tablets, 35 mg...
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AstraZeneca sued four generic drugmakers, this week in New Jersey federal court, accusing the pharmaceutical companies of infringing on its patent for the arthritis medication Vimovo...
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On October 25, 2013, the law firm of Rochon Genova issued a class action on behalf of users of generic versions of diabetes drug Actos (Pioglitazone hydrochloride) against generic manufacturers and distributors Apotex and Sandoz...
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Actavis today confirmed that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Clindamycin phosphate and Benzoyl peroxide gel, 1.2%/2.5%...
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Coherus today announced that its proposed Etanercept biosimilar molecule, CHS-0214, an investigational drug, met the primary endpoint of clinical pharmacokinetic (PK) similarity to Enbrel in a confirmatory clinical study in healthy subjects meeting US, EU, and Japanese regulatory requirements for clinical PK similarity...
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Sun said it addressed Food and Drug Administration concerns about quality-control breaches at a U.S. subsidiary that was shut down by the regulator for three years because of manufacturing flaws...
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Germany's Stada will sell a version of U.S. drugmaker Amgen's blockbuster cancer treatment Filgrastim in Europe, keeping faith with the difficult market for copies of medicines developed using biotechnology...
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In a way, the coming year isn't a big one for patent expirations...
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The hearing in the high voltage Nexavar case by German drug major Bayer against India's first ever compulsory license (CL) to Natco Pharma will begin in Bombay High Court on October 29...
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Available only to the public health sector, and authorised, non-retail prescribers, Aubra (Levonorgestrel and Ethinyl Estradiol tablets, USP 0.1mg/0.02mg) is an AB rated, generic contraceptive
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AstraZeneca today announced that the United States Court of Appeals for the Federal Circuit has reversed and remanded for further proceedings a trial court decision that generic defendants involved in the litigation do not infringe a patent (US Patent No. 7,524,834) protecting Pulmicort Respules in the US...
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The patent protection for Viagra has fallen - and therefore the price of power means with the same active ingredient. Who does not get an erection, but should not equal demand a pill from his doctor...
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Impax and Tolmar today announced that the U.S. Food and Drug Administration has granted final approval of Tolmar's Abbreviated New Drug Application for its generic version of Solaraze gel Diclofenac sodium 3%...
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The Patent Office rejected the compulsory licensing application of Mumbai-based BDR Pharmaceuticals to make a generic version of US drug maker Bristol-Myers Squibb's anticancer drug Dasatinib, sold under the brand name Sprycel...
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Actavis today confirmed that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Isotretinoin capsules, 10 mg, 20 mg, 30 mg and 40 mg...
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