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   May 2015 News Archive news archive  


04/05/2015  Teva initiates voluntary nationwide recall of select lots of Adrucil injections due to particulate matter news archive
Teva today announced a voluntary recall of eight lots of Adrucil (Fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals...
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04/05/2015  Teva launches new generic FazaClo strengths news archive
Teva announced the launch of two new strengths of Clozapine ODT (orally disintegrating tablets), the generic version of Jazz Pharmaceutical's FazaClo...
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04/05/2015  Vanc announces Health Canada approval for 5 new generic molecules and provides commercialisation update news archive
Vanc is pleased to announce that is has received DINs from Health Canada for 5 new generic molecules as an initial notice of consent for new drug submissions...
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04/05/2015  Glenmark receives tentative ANDA approval for Calcipotriene cream, 0.005 % news archive
Glenmark has been granted tentative approval by the FDA for Calcipotriene cream 0.005 %, the therapeutic equivalent of Dovonex topical cream of Leo...
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05/05/2015  Mylan launches generic Seasonale tablets news archive
Mylan today announced the US launch of Levonorgestrel and Ethinyl estradiol tablets USP, 0.15 mg/0.03 mg, which is the generic version of Teva's Seasonale tablets...
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05/05/2015  Mylan confirms first-to-file patent challenge relating to Minivelle news archive
Mylan today confirmed that it has been sued by Noven and Hisamitsu, in connection with the filing of an ANDA with the FDA for Estradiol transdermal system...
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05/05/2015  GlaxoSmithKline and Apotex sue Lupin over generic Paxil drug news archive
A unit of GlaxoSmithKline, the UK's largest drugmaker, joined with Canadian business partner Apotex, to sue Indian generic pharmaceutical firm Lupin over plans to market copies of the antidepressant Paxil...
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07/05/2015  Actavis to re-launch generic Pulmicort respules following favourable Appeals Court ruling news archive
Actavis today announced that it will immediately re-launch its generic version of AstraZeneca's Pulmicort respules (Budesonide inhalation suspension) 0.25 and 0.5 mg vials following a decision from the United States Court of Appeals...
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07/05/2015  Noven, Hisamitsu sue Mylan on generic Minivelle news archive
Mylan, a global pharmaceutical company, have been sued by Noven and Hisamitsu in connection with the filing of an ANDA with the FDA for Estradiol transdermal system, USP, twice-weekly 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day...
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07/05/2015  Court temporarily blocks US sale of Novartis' biosimilar news archive
A US Appeals Court has temporarily blocked the sale of Novartis' Zarxio, a biosimilar version of Amgen's Neupogen, until a legal battle between the companies is settled...
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08/05/2015  Eisai to import ingredients for generics from India news archive
Japan's Eisai will begin importing ingredients from India in order to create high-quality generic drugs cheaply...
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08/05/2015  Horizon announces settlement of Pennsaid 2% patent litigation with Perrigo news archive
Horizon, today announced that its affiliates have entered into a settlement and license agreement with Perrigo, to resolve pending patent litigation involving Pennsaid (Diclofenac sodium topical solution) 2 %w/w (Pendsaid 2 %)...
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14/05/2015  Epirus Biopharmaceuticals and mAbxience sign Latin America distribution deal for Infliximab biosimilar, BOW015 news archive
Epirus Biopharmaceuticals, and mAbxience, a biopharmaceutical company specialised in research, development and manufacturing of biosimilars, entered into a development and future distribution deal for Epirus' lead program...
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15/05/2015  Supreme Court restrains Glenmark from producing anti-diabetes medicines news archive
In a relief to US pharm major Merck Sharp and Dohme, the Supreme Court today restrained Indian firm Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes...
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16/05/2015  US lawsuit puts generic drug imports from India under scanner news archive
A US class action lawsuit accusing India's Ranbaxy of large-scale deception on its generic drug applications puts a question mark on drug imports from India, the largest supplier of generic drugs to the US...
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19/05/2015  Teva launches generic Atelvia news archive
Teva announced the launch of Risedronate sodium delayed-release tablets, the generic version of Warner Chilcott's Atelvia...
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20/05/2015  Neos therapeutics announces trade name Cotempla XR-ODT for its Methylphenidate extended-release orally disintegrating tablets news archive
Neos Therapeutics today announced that the U.S. FDA has provisionally accepted the trade name Cotempla XR-ODT for its Methylphenidate extended-release orally disintegrating tablets...
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20/05/2015  Neos announces trade name Cotempla XR-ODT for its Methylphenidate extended-release orally disintegrating tablets news archive
Neos, a company with three late-stage extended-release (XR) product candidates for the treatment of ADHD currently in development, today announced that the FDA has provisionally accepted the trade name Cotempla XR-ODT for its methylphenidate extended-release orally disintegrating tablets...
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20/05/2015  Gilead patents on costly hepatitis C drug challenged in five countries news archive
A US group is trying to block patents in five countries for Gilead costly hepatitis C drug Sovaldi, in a bid to give almost 60 million afflicted people access to cheaper generic versions...
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21/05/2015  Glenmark gets tentative USFDA nod to sell Rufinamide news archive
Glenmark Pharmaceuticals today said it has been granted tentative approval by the US health regulator to sell Rufinamide, which is used to treat seizures caused by Lennox-Gastaut syndrome...
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21/05/2015  HIV activists fight hep C drug patent news archive
HIV/Aids patients and civic groups yesterday demanded the government not approve a private drug giant's request for a hepatitis C drug patent in Thailand...
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22/05/2015  Actavis confirms appeals court ruling requiring continued distribution of Namenda IR news archive
Actavis today confirmed that a panel of the U.S. Court of Appeals for the Second Circuit has issued a ruling upholding a December 15, 2014 preliminary injunction requiring the company to continue distribution of Namenda (Memantine HCl) immediate-release tablets...
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27/05/2015  Par receives favorable appeals court ruling in generic Exelon patch litigation news archive
Par today announced that the United States Court of Appeals for the Federal Circuit has upheld the U.S. District Court for the District of Delaware's earlier ruling that Par's filing of an ANDA for its generic version of Novartis' Exelon patch (Rivastigmine transdermal system) does not infringe United States Patent Nos. 6,316,023 or 6,335,031...
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27/05/2015  Aurobindo files ANDA for HIV generic drug news archive
India's Aurobindo has submitted an ANDA for Dolutegravir 50 mg, for tentative approval to the FDA, for the treatment of HIV....
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28/05/2015  Novo Nordisk, Baxter clash over haemophilia drug patent news archive
Novo Nordisk on Wednesday rejected claims by Baxter that its drug used substances developed by the US rival, following the launch this week of a US investigation into possible patent infringement...
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28/05/2015  Amarin granted summary judgment motion in suit against FDA seeking New Chemical Entity market exclusivity for Vascepa capsules news archive
Amarin announced today that Judge Randolph D. Moss of the federal district court for the District of Columbia has granted Amarin's motion for summary judgment in the company's lawsuit against the FDA seeking an order requiring FDA to recognize five-year, NCE, marketing exclusivity for Vascepa (Icosapent ethyl) capsules...
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28/05/2015  IGI announces third ANDA submission Of 2015 news archive
IGI, a New Jersey based specialty generic pharmaceutical company, today announced it has submitted its third ANDA to the FDA of 2015, which brings the Company's total number of ANDA submissions now pending at the FDA to twenty-five....
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29/05/2015  Teva enhances extensive women's health portfolio with launch of generic Lomedia 24 Fe tablets news archive
Teva announces the launch of the generic equivalent of Lomedia 24 Fe (Norethindrone acetate and Ethinyl Estradiol tablets USP...
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29/05/2015  Glenmark gets USFDA nod for generic diabetes treatment drug news archive
Glenmark today said it has received the final approval from US health regulator for its generic version of Desmopressin acetate tablets...
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