Generics Industry News Search
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March 2015 News Archive |
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Cosmo Pharmaceuticals informs that Santarus a wholly owned subsidiary of Salix Pharmaceuticals, and its subsidiary, Cosmo, the licensor, commenced a lawsuit against generic drug maker Alvogen for Alvogens' infringement of certain patents listed in the FDA's Orange Book covering Uceris and its use...
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Jubilant Life Sciences, has received ANDA final approval from the FDA for Montelukast sodium chewable tablets, 4 mg and 5 mg, the generic version of Singulair...
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Natco announced today that it has signed a nonexclusive licensing agreement with Gilead Sciences, to manufacture and sell generic versions of its chronic hepatitis C medicines...
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A US court has upheld the decision by the FDA to cancel the approvals given to Ranbaxy to sell and market the generic versions of AstraZeneca's heartburn medicine Nexium and Roche's anti-viral medicine Valcyte...
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Actavis today confirmed that the United States District Court for the District of New Jersey has found that United States patent nos. 7645459 and 7645460 protecting Atelvia (Risedronate sodium delayed-release tablets, 35 mg) in the US, are invalid...
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ANI Pharmaceuticals today announced that it has acquired the approved ANDA for Flecainide acetate tablets USP 50mg, 100mg and 150mg, previously marketed by Teva...
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The German Court of Appeal has ruled that Eli Lilly and Company's vitamin regimen patent for Alimta (Pemetrexed disodium) would not be infringed by a generic competitor that intends to market a dipotassium salt form of Pemetrexed in Germany once the compound patent expires in December 2015...
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Hospira applauds Sandoz and the FDA on today's FDA approval of the first biosimilar in the United States...
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Sandoz, a Novartis company, announced today that the FDA approved Zarxio (Filgrastim-sndz) for all indications included in the reference product's label...
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Natco has launched the first generic version of Sofosbuvir in Nepal. Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences under its brand Sovaldi...
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Actavis today announced that it has launched a generic version of Fougera's Temovate (Clobetasol cream 0.05%) in the US...
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The FDA has announced the release of new documents meant to make it easier for generic manufacturers to introduce competition to 38 existing drug products, including popular new drugs like Stendra, Belviq, Kalydeco and Brilinta...
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India's Patent Office has revoked a patent on asthma drug, Spiriva held by German major Boehringer Ingelheim on an opposition filed by generic company, Cipla...
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Natco announced today that it is pleased with the US Supreme Court's decision to deny Certiorari for the generic version of Tamiflu oral capsules...
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ANI Pharmaceuticals today announced the launch of Etodolac 200mg oral capsules, indicated for use in the management of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and acute pain...
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In a setback to Bayer Healthcare, the Indian Patent Office has dismissed a patent application by the drug company for a salt form of its anti-cancer drug Sorafenib, known under the brand Nexavar...
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Mylan today announced the US launch of Buprenorphine hydrochloride sublingual tablets, 2 mg and 8 mg, which is the generic version of Reckitt Benckiser's Subutex sublingual tablets...
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Mylan today announced the US launch of Disulfiram tablets USP, 250 mg and 500 mg, which is the generic version of Odyssey Pharmaceutical's Antabuse...
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Mylan today announced the US launch of its Fentanyl transdermal system 37.5, 62.5 and 87.5 mcg/hr, adding to its existing offering of Fentanyl transdermal system 12, 25, 50, 75 and 100 mcg/hr...
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Afaxys today announced the nationwide launch of EContra EZ (Levonorgestrel 1.5 mg), Afaxys' first over-the-counter emergency contraceptive offered to the public health sector...
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Akorn today announced several generic product launches that build on Akorn's commitment to serve the company's specialty generic customers and patients...
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Actavis today confirmed that the United States Court of Appeals for the Federal Circuit has granted AstraZeneca's request for an injunction pending appeal preventing Actavis from further distribution of its generic version of Pulmicort respules 0.25, 0.5 mg...
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Glenmark announced today that is has received approval for Salmecort (Salmeterol and Fluticasone) MDI inhaler from the Ministry of Health, Russia...
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Natco is pleased to announce that it is the 1st company in India to get approval for generic Sofosbuvir tablets, 400mg, from Drugs Controller General...
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Hetero today announced that it has received approval for generic Sofosbuvir tablets 400 mg, from Drug Controller General of India...
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Breckenridge announced today that it has filed an ANDA with a Paragraph IV certification for Dabigatran etexilate mesylate capsules EQ 75 mg and EQ 150 mg strengths, a generic version of Pradaxa by Boehringer Ingelheim...
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Samsung Bioepis today announced that the Marketing Authorisation Application for SB2, its Remicade (Infliximab) biosimilar candidate, has been submitted to the EMA...
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Recently, the FDA listed Kitabis Pak as a therapeutic equivalent of TOBI (Tobramycin inhalation solution, USP) in their Orange Book...
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The Generic Medicines Industry Association (GMiA) will today launch the GMiA Guide to Biosimilars during a Parliamentary Friends of Medicine event at Parliament House...
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TWi Pharmaceuticals, announced today that its wholly-owned subsidiary, TWi Pharmaceuticals USA, shipped the first generic product in its own label on March 16, 2015...
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InSite Vision today announced that it, along with other plaintiffs, has entered into a settlement agreement to dismiss a patent infringement lawsuit against Mylan Pharmaceutical concerning Mylan's ANDA seeking marketing approval from the FDA of a 1% azithromycin ophthalmic solution before the expiration of the patents protecting AzaSite...
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The breakthrough oral therapy, 'SoviHep' which will provide succour to more than 10 million patients who suffer from Hepatitis C in India has been launched by the Zydus group...
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Australia's consumer watchdog will appeal against a federal court decision that found the pharmaceutical giant Pfizer had not engaged in anti-competitive conduct...
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Clarithromycin HEC (a generic to the pharmaceutical product Klacid) has been launched in Sweden, consistently with HEC's previously communicated goals...
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Aurobindo is pleased to announce that the FDA has granted the tentative approval for Lacosamide tablets 50mg, 100mg, 150mg and 200mg...
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A US judge on Thursday denied Amgen's bid to block the sale of Novartis's recently approved biosimilar form of Neupogen, a blockbuster drug used to prevent infections in cancer patients...
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Akorn today announced that it has launched Phenylephrine HCl ophthalmic solution, USP, 2.5% and 10%...
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Noven announced today that it has filed a lawsuit in the U.S. District Court of Delaware against Actavis for patent infringement...
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Dr Reddy's Laboratories today entered into an agreement with Hetero to distribute and market generic version of Gilead Sciences' Hepatitis C drug under the brand 'Resof' in India...
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Shares of Glenmark were down nearly 2% at Rs 816 on talk that the Delhi High Court has restrained the company from manufacture and marketing of Zita, Zita-Met which are dispensed for the treatment of diabetes...
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Noven announced today that it has filed a lawsuit in the U.S. District Court of Delaware against Actavis for patent infringement...
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Mallinckrodt confirmed today that the US Federal Circuit Court of Appeals has affirmed findings of the US District Court of Delaware in the case of Cadence Pharmaceuticals and SCR Pharmatop vs. Exela...
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Teikoku announced today that it has submitted a 505(b)(2) ANDA to the FDA for Docetaxel injection concentrate, non-alcohol formula on February 26, 2015 and received an acknowledgment of the receipt from FDA...
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Glenmark has petitioned the Supreme Court against an order of the high court in India, barring it from selling anti-diabetic drugs Zita and Zita-Met...
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German generic drugmaker Stada struck an alliance with family-owned Hetero Drugs of India to gain access to active ingredients for cancer drugs, Stada said on Thursday...
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IGI Laboratories today announced it has submitted its first ANDA to the FDA of 2015...
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Hospira, a global leader in biosimilars and the world's leading provider of injectable drugs and infusion technologies, presented two studies that support an evaluation of biosimilarity of its proposed biosimilar, Epoetin Hospira, with the FDA conditionally approved name of Retacrit, compared to the reference product, Amgen's Epogen...
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Stides Arcolab today announced the launch of generic drug Sofosbuvir in India under the brand name Virso...
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Intas has launched Intacept, the first biosimilar to Amgen's Enbrel...
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Japan's Otsuka Pharmaceuticals accused the FDA in a unique court suit of manipulating its regulatory procedures to kill off its 7-year exclusivity to market Abilify for treating Tourette syndrome in children...
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Hospira announces the availability of Inflectra (Infliximab) in Canada...
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Teva Canada, announced that Health Canada has approved its application for the generic version of Bortezomib...
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Pfizer's unprecedented effort to fight Lyrica copies in England has doctors and pharmacists squabbling, and the National Health Service stepping in to keep the peace...
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ANI Pharmaceuticals today announced the launch of Propafenone hydrochloride 150mg, 225mg and 300mg oral tablets, indicated for use in the treatment of various arrhythmias...
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Teva announces the launch of the generic equivalent to Exforge (Amlodipine and Valsartan) tablets in four different strengths, in the US...
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Mylan today announced the US launch of Amlodipine and Valsartan tablets, 5 mg/160 mg, 5 mg/320 mg, 10 mg/160 mg, 10 mg/320 mg, which is the generic version of Novartis' Exforge tablets...
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