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   August 2014 News Archive news archive  


01/08/2014  ANI Pharmaceuticals acquires Vancocin capsules and additional Vancomycin assets from Shire news archive
ANI Pharmaceuticals today announced that it has acquired the US rights for Vancocin 125 mg and 250 mg capsules from Shire, a global biopharmaceutical company...
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03/08/2014  CCI to scan drug patent settlements news archive
The country's competition regulator may examine details of patent settlements being negotiated between foreign branded medicine companies and local generic drug makers as these agreements may restrict the access of cheaper drugs to the sick...
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04/08/2014  Lannett receives FDA approval for Oxycodone hydrochloride capsules 5 mg news archive
Lannett today announced that it has received approval from the FDA of its ANDA for Oxycodone hydrochloride capsules...
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04/08/2014  India, China to produce generic of Gilead's TAF news archive
Gilead have allowed generic manufacturers in India and China to produce generic versions of its HBV and HIV drug, Tenofovir Alafenamide...
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04/08/2014  Judge rejects Takeda's tactic in generics fight news archive
A federal judge has cried foul over punches thrown by Takeda Pharmaceutical in a patent brawl to decide the fate of a planned generic for its acid reflux drug...
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05/08/2014  Heritage signs exclusive development supply & distribution agreement with Dexcel news archive
Heritage Pharmaceuticals has signed an exclusive development, supply & distribution agreement with Dexcel for an extended release ANDA drug product...
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06/08/2014  Alvogen buys South Korean generics drugmaker for $187 million news archive
Generic drugmaker Alvogen said it had agreed to buy South Korea's Dream Pharm for $187 million in cash as part of a push into Asia by the fast-growing U.S.-based company...
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06/08/2014  Mallinckrodt Pharmaceuticals announces settlement of Ofirmev Acetaminophen injection patent litigation with Fresenius Kabi news archive
Mallinckrodt today announced that its subsidiary, Cadence, has entered into settlement and license agreements with Fresenius Kabi resolving pending patent litigation involving Ofirmev...
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06/08/2014  Pfizer to pay $35 million to U.S. states to settle Rapamune claims news archive
Pfizer agreed to pay $35 million (20.7937 British million pounds) to 41 U.S. states and Washington, D.C. to settle claims that its Wyeth unit illegally marketed the drug Rapamune...
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06/08/2014  Mallinckrodt Pharmaceuticals announces settlement of Ofirmev injection patent litigation with Fresenius Kabi news archive
Mallinckrodt today announced that its subsidiary, Cadence Pharmaceuticals, has entered into settlement and license agreements with Fresenius Kabi USA...
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07/08/2014  Zydus Cadila gets FDA nod for kidney stones tablets news archive
Drug firm Zydus Cadila has received the final approval from the US health regulator to market Potassium Citrate ER tablets used in prevention of kidney stones...
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08/08/2014  Pfizer confronts surge of lawsuits over Lipitor news archive
Pharmaceutical giant Pfizer is facing a mounting wave of lawsuits by women who allege that the company knew about possible serious side effects of its blockbuster anti-cholesterol drug Lipitor but never properly warned the public...
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10/08/2014  Teva to sue Dr. Reddy's over generic Copaxone news archive
Teva Pharmaceutical has confirmed that it has received the first paragraph IV notice for a generic version of its three-times-a-week Copaxone 40 mg/mL treatment...
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10/08/2014  Norway approves new Viagra generic drug to fight against online fraud news archive
The Norwegian Medicines Agency approves new potency agent in Norway...
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11/08/2014  Mylan launches generic Xeloda tablets news archive
Mylan today announced that it has launched Capecitabine tablets USP, 150 mg and 500 mg, the generic version of Genentech's Xeloda tablets...
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11/08/2014  FDA receives first-ever biosimilar application for monoclonal antibody news archive
South Korean biopharmaceutical manufacturer Celltrion has announced that it has filed an application for approval with the U.S. FDA for Remsima...
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11/08/2014  Mylan launches generic Xeloda tablets news archive
Mylan today announced that it has launched Capecitabine tablets USP, 150 mg and 500 mg, the generic version of Genentech's Xeloda tablets...
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12/08/2014  Sanofi launches authorised generic version of Eloxatin Oxaliplatin injection news archive
Sanofi announced today that it has launched an authorised generic version of Eloxatin (Oxaliplatin injection) through Winthrop...
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12/08/2014  Health Ministry continues to push for generic version of cancer drug news archive
The Health Ministry has sent a fresh communication to the Department of Industrial Policy & Promotion on why there was an "urgent" need to allow copies of Bristol Myer Squibb's anti-cancer drug Dasatinib to be made in India...
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12/08/2014  International collaboration for the evaluation of generic drugs news archive
The TGA has agreed, in principle, to participate in a pilot of the Decentralised Procedure (DCP) of the European Union...
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13/08/2014  Generic Viagra delivers hidden billionaire duo in Brazil news archive
The day after Pfizer's patent for Viagra expired in Brazil, Carlos Sanchez flooded pharmacies with his generic erectile dysfunction pills...
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13/08/2014  Amneal Pharmaceuticals announces four new generics news archive
Amneal Pharmaceuticals' fast-growing portfolio of approved generic drugs is expanding once again with the launch of four new medications...
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14/08/2014  Napp to sell Celltrion's Remicade biosimilar in UK news archive
Napp Pharmaceuticals has bagged exclusive rights to distribute Celltrion's biosimilar of Johnson and Johnson and Merck and Co's anti-inflammatory blockbuster Remicade in the UK...
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15/08/2014  Gilead says panel rejects Roche's claims on hep C drug news archive
Gilead said an arbitration panel rejected Roche's patent infringement claims related to Gilead's hepatitis C drug, Sovaldi...
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18/08/2014  FDA grants tentative approval for Lilly and Boehringer Ingelheim's Basaglar news archive
The U.S. FDA today granted tentative approval for Basaglar (Insulin Glargine injection), which is indicated to improve glycaemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and paediatric patients with type 1 diabetes...
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19/08/2014  Rise in ex-parte orders upset generic drugmakers' future business plans news archive
A growing number of cases in the pharma sector, where courts forbid Indian drugmakers from launching generic versions of patented drugs...
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19/08/2014  Govt set to revise patent norms for pharma news archive
The government is set to revise the guidelines for evaluating applications seeking intellectual property rights for pharmaceuticals...
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19/08/2014  Hospira sues U.S. FDA over approval of generic sedative news archive
Drugmaker Hospira Inc has sued the FDA over its decision to open the doors for competitors to sell generic versions of its patented sedative, Precedex...
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19/08/2014  Depomed prevails in Gralise ANDA litigation blocking generic entry until 2024 news archive
Depomed today announced Judge Joel A. Pisano of the U.S. District Court for the District of New Jersey has ruled in favour of Depomed in the company's patent litigation lawsuit against Actavis...
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19/08/2014  Mylan launches generic Precedex injection - another key product approval news archive
Mylan announced that its business Mylan Institutional has launched Dexmedetomidine hydrochloride injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL Single-dose Vials, which is therapeutically equivalent to Hospira's Precedex...
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20/08/2014  U.S. judge blocks FDA rule allowing generic versions of Hospira drug news archive
A federal judge has issued a temporary restraining order against the U.S. FDA's decision to allow the sale of generic versions of the Hospira sedative Precedex...
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20/08/2014  Lannett to acquire two generic pharmaceutical products news archive
Lannett Company today announced that it has agreed to purchase ANDAs for Estradiol Tablets...
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20/08/2014  Amerigen announces that its Chinese subsidiary, Suzhou Amerigen, has received CFDA approval and has subsequently launched its generic Mecobalamin 0.5 mg tablets news archive
Amerigen announces that its Chinese subsidiary, Suzhou Amerigen, has received CFDA approval and has subsequently launched its generic Mecobalamin 0.5 mg tablets into the China domestic market...
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21/08/2014  Supernus announces paragraph IV ANDA filing for Trokendi XR news archive
Supernus Pharmaceuticals today announced that on August 20, 2014, the Company received a Paragraph IV Notice Letter from Actavis...
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22/08/2014  Mylan launches first generic Klor-Con extended-release tablets news archive
Mylan today announced that it has launched Potassium Chloride extended-release tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg), which is the generic version of Upsher-Smith's Klor-Con...
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22/08/2014  Actavis confirms generic Neupro patent challenge news archive
Actavis today confirmed that it has filed an ANDA with the U.S. FDA seeking approval to market Rotigotine extended-release transdermal film, 1 mg/24 hr, 2mg/24 hr, 3 mg/24hr, 4 mg/24 hr, 6mg/24hr, and 8 mg/24 hr...
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25/08/2014  Vivus announces acquisition of Topiramate-related patents from Janssen Pharmaceuticals news archive
Vivus today announced the acquisition of a group of patents from Janssen covering uses of Topiramate...
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25/08/2014  Fera Pharmaceuticals announces launch of Moxatag authorised generic news archive
Fera Pharmaceuticals is pleased to announce that it has been selected by Pragma Pharmaceuticals to launch Amoxicillin extended-release tablets, the authorised generic for Moxatag...
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25/08/2014  VIVUS announces acquisition of Topiramate-related patents from Janssen Pharmaceuticals news archive
VIVUS today announced the acquisition of a group of patents from Janssen Pharmaceuticals, covering uses of Topiramate as monotherapy and in combination with other pharmaceutical agents to treat a variety of medical conditions...
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26/08/2014  Strides gets United States FDA nod for generic anti-anxiety tablets news archive
Drug firm Strides Arcolab today received approval from the US health regulator for its generic...
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26/08/2014  Apotex president and chief executive Jeremy Desai said the company was disappointed by the decision. news archive
"We remain strongly committed to the U.S. market and we continue to work closely with the FDA to resolve all outstanding issues and to achieve our shared objective of expanding the public's access to quality...
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26/08/2014  Sandoz Brazil introduces a new option for oncology patients news archive
Sandoz, the generic pharmaceutical division of Novartis, today announces the market introduction in Brazil of the first generic version of oncology medicine Bortezomib...
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28/08/2014  TWi Pharmaceuticals receives US FDA final approval on generic Megestrol acetate 125 mg/ml oral suspension news archive
TWi Pharmaceuticals today announced that it has received final approval from the United States FDA on its ANDA for Megestrol acetate 125mg/ml oral suspension...
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28/08/2014  Mylan's ANDA for three times per week generic Copaxone 40 mg/ml accepted for filing by FDA news archive
Mylan today announced that its ANDA for a three times per week Glatiramer acetate injection 40 mg/ml has been accepted for filing...
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28/08/2014  Momenta Pharmaceuticals announces ANDA for three-times-a-week generic Copaxone accepted for review by FDA news archive
Momenta today announced that the FDA has accepted for review the ANDA for a three-times-a-week generic Copaxone...
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29/08/2014  District court decision received in Remodulin patent case news archive
United Therapeutics Corporation announced today that the U.S. District Court for the District of New Jersey has ruled in its favor in the company's case against Sandoz regarding United Therapeutics' Remodulin product...
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29/08/2014  Sandoz launches generic version of Dacogen news archive
Sandoz today announced the US market introduction of Decitabine for injection, a generic version of Eisai's Dacogen...
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31/08/2014  Inhaled Insulin, biosimilars will change the landscape of diabetes care news archive
Insulin Glargine injections (Basaglar) and inhaled Insulin (Afrezza) are two new diabetes treatment options worth exploring...
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