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   December 2014 News Archive news archive  


01/12/2014  IGI Laboratories announces 8th ANDA submission of 2014 news archive
IGI Laboratories today announced it has submitted an additional ANDA to the U.S. FDA, which brings the Company's total number of ANDA submissions in 2014 to eight...
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01/12/2014  Actavis launches generic version of Intuniv news archive
Actavis today announced that it has launched a generic version of Intuniv (Guanfacine hydrochloride)...
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01/12/2014  Ranbaxy launches India's first biosimilar of Infliximab drug, Infimab news archive
Ranbaxy today announced the launch of Infimab (BOW015), the first Remicade (Infliximab) biosimilar in India...
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01/12/2014  Teva announces launch of generic Exforge HCT tablets in the United States news archive
Teva Pharmaceutical announces the launch of the generic equivalent to Exforge HCT (Amlodipine, Valsartan, hydrochlorothiazide)...
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01/12/2014  FDA delays ruling on Teva petition against generic Copaxone for MS news archive
Teva Pharmaceutical, the company behind multiple sclerosis drug Copaxone (Glatiramer acetate injection), has been pursuing the US FDA's decision against approving a generic version of the drug, by Mylan...
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01/12/2014  Heritage Pharma announces the launch of Furosemide for injection news archive
Heritage announced the immediate availability of Furosemide injection...
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01/12/2014  Heritage Pharma announces the launch of Felodipine extended-release tablets news archive
Heritage announced the immediate availability of Felodipine extended-release tablets...
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02/12/2014  Epirus Biopharmaceuticals Remicade biosimilar, Infimab, launches in India news archive
Epirus today announced the launch of its first product, Infimab...
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03/12/2014  Perrigo announces FDA approval and launch of the generic version of Pennsaid news archive
Perrigo today announced that it has received final approval from the FDA on its ANDA for Diclofenac sodium topical solution...
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03/12/2014  Meda and Cipla sue Apotex to enforce Dymista patents news archive
Sweden-based drug firm Meda Pharmaceuticals and Cipla have "sued" Apotex Inc and Apotex Corp in Federal District Court in Delaware in US to enforce patents of its allergy drug 'Dymista'...
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04/12/2014  FDA pressed to act on biosimilar drugs news archive
The FDA admits it has been slow to issue guidance on biosimilar drugs that are expected to hit the U.S. market next year...
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05/12/2014  Sandoz loses bid to shield psoriasis drug news archive
The top U.S. patent appeals court has upheld the dismissal of a lawsuit brought by Sandoz that sought to shield its planned version of Amgen's psoriasis and arthritis drug...
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06/12/2014  GVK Biosciences manipulated results of generic drug trials: Reports news archive
GVK BIO allegedly manipulated the results of clinical trials of generic drugs it carried out on behalf of several European manufacturers, say some German media reports...
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06/12/2014  AstraZeneca-Ranbaxy drug settlement not anti-competitive news archive
In a landmark judgement for pharma sector, a US jury has ruled that AstraZeneca's patent litigation settlement for blockbuster drug Nexium with Ranbaxy was not anti-competitive...
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08/12/2014  Phase III data shows Sandoz' investigational biosimilar Filgrastim has similar safety and efficacy as Amgen's Neupogen news archive
Sandoz, a Novartis company, announced today Phase III data that demonstrated similarity of its investigational biosimilar Filgrastim compared to the US-licensed reference product, Amgen's Neupogen (Filgrastim)...
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08/12/2014  Cubist barred from blocking generic beyond 2016 news archive
Cubist Pharmaceuticals, the drugmaker being bought by Merck & Co. for $8.4 billion, lost a bid to block Hospira from offering a generic version of its top-selling Cubicin treatment for flesh-eating infections beyond 2016...
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08/12/2014  Teva Canada announces the launch of Teva-Erlotinib, a generic of Tarceva news archive
Teva Canada announced today that Health Canada has approved its application for the generic version of Tarceva...
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09/12/2014  Supernus announces Paragraph IV ANDA filing for Trokendi XR news archive
Supernus Pharmaceuticals today announced that on December 8, 2014 the Company received a Paragraph IV Notice Letter from Par Pharmaceutical advising...
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09/12/2014  Zydus launches world's first biosimilar of Adalimumab news archive
After more than a decade long wait, the revolutionary therapy that provided a new lease of life to millions of patients suffering from rheumatoid arthritis and other auto immune disorders globally will now be accessible to patients in India...
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10/12/2014  Supernus announces Paragraph IV ANDA filing for Oxtellar XR news archive
Supernus today announced that on December 9, 2014 the company received a Paragraph IV notice letter from TWi...
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10/12/2014  Teva announces launch of first generic Celebrex capsules in the U.S. news archive
Teva announces the launch of the first FDA-approved generic equivalent to Celebrex...
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10/12/2014  Actavis launches generic version of Celebrex news archive
Actavis today announced that it has launched a generic version of Celebrex...
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10/12/2014  Mylan launches one of first available generic versions of Celebrex capsules news archive
Mylan today announced the U.S. launch of its Celecoxib capsules...
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11/12/2014  Germany bans 80 generic drugs for insufficient trials news archive
Germany's drug regulator has banned the sale of 80 generic medicines...
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11/12/2014  Actavis confirms District Court ruling to require continued distribution of Namenda IR news archive
Actavis today confirmed that Judge Robert Sweet of the U.S. District Court for the Southern District of New York has announced...
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11/12/2014  Mylan launches first generic version of Orapred ODT news archive
Mylan today announced the U.S. launch of its Prednisolone sodium phosphate orally disintegrating tablets...
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11/12/2014  Wilshire confirms first-to-file patent challenge relating to Lastacaft news archive
Wilshire today confirmed that it has been sued by Allergan...
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11/12/2014  Mylan launches generic Robaxin injection news archive
Mylan today announced the U.S. launch of its Methocarbamol injection...
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11/12/2014  Lupin launches authorised generic for Celebrex capsules news archive
Lupin has launched the authorised generic for Searle's (a subsidiary of Pfizer) Celebrex capsules (Celecoxib) 50 mg, 100 mg, 200 mg and 400 mg strengths...
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11/12/2014  Teva intros generic Xopenex inhalation solution news archive
Teva Pharmaceuticals on Thursday announced the availability of Levalbuterol inhalation solution...
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12/12/2014  Bayer fails to block generic cancer drug in Indian's top court news archive
German drugmaker Bayer has failed in a last-ditch attempt to block the sale of a cheap generic version of its cancer drug Nexavar in India, after the country's Supreme Court ruled against it on Friday...
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12/12/2014  Daiichi Sankyo launches new generic drugs through its Daiichi Sankyo Espha subsidiary news archive
Daiichi Sankyo announced that its generics subsidiary, Daiichi Sankyo Espha, today launched nine new generic drugs with three new active ingredients...
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15/12/2014  Actavis will appeal injunction requiring continued distribution of Namenda news archive
Actavis today confirmed that it is filling an emergency appeal to the U.S. Court of Appeals for the Second Circuit seeking to...
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16/12/2014  Sandoz recalls generic Atacand that Mylan manufactures in India news archive
Novartis' generic division, Sandoz, is having to recall one lot of its generic version of AstraZeneca's blood pressure drug Atacand...
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16/12/2014  Dr. Reddy's announces the launch of Valganciclovir tablets, USP news archive
Dr. Reddy's announced today that it has launched Valganciclovir tablets...
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17/12/2014  German ban on generic drugs not applicable to 18 of them news archive
Germany's drug regulator has said that its ban on the sale of 80 generic medicines subjected to clinical trials by India's GVK Biosciences will not be applicable for...
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17/12/2014  US court delays Teva launch of generic Celebrex news archive
Teva has lost its 180 days exclusivity for the generic version of Pfizer's arthritis and chronic pain treatment...
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17/12/2014  Apotex announces FDA has accepted for filing its biosimilar application for Pegfilgrastim news archive
Apotex announced today that the FDA has accepted for filing the company's application for Pegfilgrastim...
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17/12/2014  HC reserves order on Novartis-Cipla drug dispute news archive
The Delhi High Court has reserved its verdict on a dispute between pharm firms Novartis and Cipla over manufacturing of the drug Indacaterol...
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18/12/2014  Lannett receives FDA approval for Dorzolamide HCl with Timolol news archive
Lannett today announced that it has received approval from the FDA of its ANDA for Dorzolamide hydrochloride and Timolol maleate ophthalmic solution...
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18/12/2014  Putney launches Carprofen chewable tablets news archive
Putney announces today that it is launching Putney Carprofen chewable tablets...
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19/12/2014  Breckenridge Pharmaceutical signs multi-product generic agreement with MSN Laboratories news archive
Breckenridge announced today that it has entered into a multi-product agreement with MSN Laboratories...
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22/12/2014  Mylan launches first generic version of Vivelle-DOT news archive
Mylan today announced the U.S. launch of its Oestradiol transdermal system USP, 0.025 mg/day, 0.0375 mg/day...
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22/12/2014  Mylan launches frst generic version of Vivelle-DOT news archive
Mylan today announced the U.S. launch of its Estradiol Transdermal System USP...
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23/12/2014  Actavis and Adamas announce FDA approval of Namzaric, a fixed-dose combination of Memantine extended-release and Donepezil hydrochloride news archive
Actavis and Adamas Pharmaceuticals today announced that the U.S.FDA has approved the ADA) for Namzaric, a fixed-dose combination (FDC) of Memantine hydrochloride extended-release, a NMDA receptor antagonist, and Donepezil hydrochloride, an acetylcholinesterase inhibitor...
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26/12/2014  Lupin receives FDA approval for generic Epivir A tablets news archive
Lupin announced today that it has received final approval for its Lamivudine tablets...
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30/12/2014  Generic antiepilepsy drugs have minimal differences: Study news archive
A comparison of two of the most disparate approved generic antiepileptic drugs found minimal differences when compared under rigorous testing procedures in people with epilepsy, according to research presented by a University of Cincinnati clinician-researcher
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30/12/2014  Lupin receives tentative approval for generic Prezista tablets news archive
Lupin announced today that it has received tentative approval for its Darunavir ethanolate tablets...
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