Generics Industry News Search
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June 2014 News Archive |
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IGI Laboratories, a New Jersey based generic topical pharmaceutical company, today announced it has submitted its second ANDA in 2014 to the U.S. FDA, which brings the Company's total number of ANDA submissions to fifteen, with thirteen now pending at the FDA...
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Mylan today announced that it has entered into a settlement and license agreement with Pfizer relating to Mylan's ANDA filed with the U.S. FDA for Celecoxib capsules, 50 mg, 100 mg, 200 mg and 400 mg...
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Sandoz, the generic pharmaceuticals division of Novartis, today announces the launch in France of Mometasone Sandoz, the first generic version of leading respiratory therapy Nasonex...
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Teva and Labrys Biologics, a privately-held development stage biotechnology company focused on treatments for chronic migraine and episodic migraine, today announced that Teva has entered into a definitive agreement to acquire Labrys...
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H2-Pharma announced today the launch of Fenofibrate 50 mg and 150 mg capsules, an authorised generic version of Lipofen...
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Aurobindo has received US health regulator's approval to market generic version of AbbVie's Depakote extended-release tablets...
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Cubist Pharmaceuticals plans to file a complaint with the FDA to block a global health care giant from selling a generic version of its flagship antibiotic, Cubicin...
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Sandoz, today announced the launch in several European countries of generic Escitalopram...
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CorePharma announced today that it has launched Dextroamphetamine sulfate tablets, the generic version of Shire's Dextrostat...
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Generic drug companies are beyond the jurisdiction of the Patented Medicine Prices Review Board, the Federal Court has ruled in twin cases involving generic drug makers Ratiopharm (now Teva Canada) and Sandoz...
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Shares of recent high-flier Merus Labsare off today after learning that competition is looking to enter a market that represents an increasing portion of its topline...
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Drug major Wockhardt is recalling over 8,000 bottles of anti-hypertension drug Metoprolol Succinate extended-release tablets in the US market following failure of a dissolution test...
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Teva announced the launch of Mimvey Lo (Estradiol and Norethindrone acetate) tablets, the generic version of Novo Nordisk's Activella...
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Oncobiologics announced that it has entered into a two-part collaboration with Ipca Laboratories for the development, manufacture, and sales of biosimilar monoclonal antibody candidates...
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Mylan today announced that it has launched Carboplatin injection, 50 mg/5 ml, in multi-dose vials, which is the generic version of Bristol-Myers Squibb's Paraplatin injection...
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Acella Pharmaceuticals, a specialty pharmaceutical company, announces the approval of an ANDA for Tranexamic acid injection...
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Actavis has informed that it has finalised agreement with Zydus Pharmaceuticals USA to settle all outstanding patent litigation related to Zydus' generic version of Asacol (Mesalamine) delayed-release tablets...
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The thrill is back for Chinese pharmaceutical companies and their investors because Pfizer is about to lose its China patent rights for the erectile dysfunction drug Viagra...
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Allergan, maker of the Botox wrinkle treatment, lost an appeals court ruling that will let generic versions of its Latisse eyelash drug enter the market...
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ACETO today announced that its Rising Pharmaceuticals, subsidiary has launched Cevimeline hydrochloride capsules, 30 mg strength, the generic version of Daiichi Sankyo's Evoxac capsules...
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Mylan today announced that it has launched Risedronate sodium tablets USP, 150 mg, the generic version of Warner Chilcott's Actonel tablets...
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Auxilium Pharmaceuticals today announced that it has partnered with Prasco to introduce an authorised generic version of Testim (Testosterone gel). Prasco has product inventory available and has commenced shipping product...
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Vivus today announced that it has filed a lawsuit in the U.S. District Court for the District of New Jersey against Actavis...
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Breckenridge Pharmaceutical announced today the immediate launch of Duloxetine delayed-release capsules...
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Teva announced that the U.S. Court of Appeals today upheld a ruling finding Bristol-Myers Squibb's Entecavir compound claim invalid...
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Ranbaxy had filed applications seeking to sell drugs in the US made at its Gurgaon plant...
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Oncobiologics announced today that it has received approval to initiate a Phase I clinical trial in Europe for its first biosimilar molecule, ONS-3010, a highly biosimilar version of the marketed drug, Humira...
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The district court of Milan, Italy denied a request from generic manufacturers to declare Alfa Wassermann's patents on Rifaximin polymorphs invalid...
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Lupin has launched its generic Ciprofloxacin, used for treating bacterial infections, in the American market and is expecting 180 days of market exclusivity...
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After fighting a long and bitter patent battle in India over lung cancer drug Tarceva (Erlotinib), Swiss innovator firm Hoffmann-La Roche and Indian generic drugmaker Cipla have entered talks through mediation to settle the matter...
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Pharmaceutical company GlaxoSmithKline has withdrawn its application for a preliminary injunction on German marketing and distribution of Sandoz's innovative and cost-effective respiratory inhaler, AirFluSal Forspiro, shortly before the Cologne Court of Appeals was due to rule in the case...
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Vanda Pharmaceuticals filed suit against Roxane Laboratories, in the United States District Court for the District of Delaware...
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Lannett today announced that it has received approval from the FDA of its ANDA for Codeine sulphate tablets USP...
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Teva announced that it has reached settlements with Sandoz, Actavis, Lupin and Apotex for Teva's wakefulness product, Nuvigil...
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If you thought the manufacturing problems that Ranbaxy Laboratories has experienced may not affect you, think again...
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IGI Laboratories today announced it has submitted its third ANDA in 2014 to the U.S. FDA...
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The Hetero Group today announced the launch of its first biosimilar product in India, Darbepoetin alfa...
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ANI Pharmaceuticals has signed an exclusive license and supply agreement with Dexcel Pharma Technologies for an ANDA drug product...
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Esteve is the first company to develop and patent an optimized formulation of Omeprazole, the most widely consumed stomach protector...
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Sandoz announces today the launch in Japan of three new products...
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EU antitrust regulators are set to fine French drugmaker Servier, Israel's Teva and several of their peers next month for blocking cheaper generic medicine, two people with knowledge of the matter said on Thursday...
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IGI Laboratories, today announced it has submitted another ANDA to the U.S. FDA, which brings the Company's total number of ANDA submissions in 2014 to four, with fifteen submissions now pending at the FDA...
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Actavis today confirmed that the United States District Court for the District of Delaware has found certain claims of United States Patent Nos. 6,335,031 and 6,316,023 valid and infringed by Actavis' generic version of Novartis' Exelon Patch...
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Teva announced that it has reached a settlement with Perrigo and Catalent with respect to four patents for Teva's ProAir HFA (Albuterol sulfate) inhalation aerosol product...
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Sun Pharma is the latest Indian drug company to have been sued by London-based AstraZeneca for alleged infringement of patents relating to its diabetes drug, Onglyza...
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Orchid Chemicals and Pharmaceuticals has surged 6% to Rs 76 on BSE after the company said it has received FDA approval for Eszopiclone tablets...
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IGI Laboratories today announced it has submitted two additional ANDA to the FDA...
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IGI Laboratories today announced it has submitted its seventh ANDA in 2014 to the FDA...
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Daiichi Sankyo Company announced that its Japan generics subsidiary...
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Breckenridge Pharmaceutical announced today that it has filed an ANDA with a Paragraph IV certification for Bendamustine hydrochloride powder for IV...
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Rockwell Medical today announced that the FDA has approved the company's sANDA to manufacture Calcitriol...
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Cephalon the drugmaker owned by Teva Pharmaceutical won a court ruling tossing claims that it conspired with makers of generics to delay cheaper versions of its sleep-disorder medicine Provigil...
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Dr Reddy's announced today that it has launched Paricalcitol capsules...
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Strides Arcolab today announced that it has received ANDA approval from the FDA for Imiquimod cream...
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Shire received a boost from the US courts on Wednesday, which blocked competitors from selling generic versions of its Vyvanse branded drug...
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Like most Hatch-Waxman attorneys, we couldn't help but notice the mysterious allure of the new inter partes review (IPR) procedure...
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The long-delayed and highly anticipated launch of generic Diovan is on the way, which is a bummer for Novartis and a huge boost for Indian drugmaker Ranbaxy Laboratories...
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Sanofi has a plant in Saudi Arabia but had decided to expand its production capacity and reach in the Middle East market with an investment in an established company there...
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Indian and US Companies making high quality, low cost generic pharmaceuticals announced the launch of "Coalition for Affordable Care" here on Wednesday...
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A pair of Republican lawmakers has written the White House to question the authority the FDA has to issue a rule allowing generic drug makers to independently provide updated safety warnings about their medicines...
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IGI Laboratories today announced that it has entered into an agreement with Mallinckrodt, and Nuvo Research (together Mallickrodt) to settle a declaratory judgment action brought by IGI...
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US biotech firm Acorda Therapeutics has been advised that Ireland-headquartered generics major Actavis has submitted an ANDA to the US FDA to market a generic version of Ampyra...
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Eli Lilly has won European backing for a generic version of Sanofi's Lantus insulin, paving the way for the first copycat of the French drugmaker's top-selling medicine...
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Dr. Reddy's Laboratories announced today that it has launched Duloxetine delayed-release capsules USP 20 mg, 30 mg and 60 mg...
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Ohm Laboratories, a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that Ohm has received approval from the U.S. FDA to manufacture and market Valsartan 40 mg, 80 mg, 160 mg, and 320 mg tablets...
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Actavis today confirmed that it has filed an ANDA with the FDA seeking approval to market Buprenorphine hydrochloride and Naloxone hydrochloride dihydrate sublingual tablets...
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Actavis and Forest today announced that the U.S. FTVC has voted to approve Actavis' proposed acquisition of Forest...
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