Generics Industry News Search
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May 2015 News Archive |
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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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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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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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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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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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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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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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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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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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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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Japan's Eisai will begin importing ingredients from India in order to create high-quality generic drugs cheaply...
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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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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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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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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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Teva announced the launch of Risedronate sodium delayed-release tablets, the generic version of Warner Chilcott's Atelvia...
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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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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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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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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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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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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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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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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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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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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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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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Teva announces the launch of the generic equivalent of Lomedia 24 Fe (Norethindrone acetate and Ethinyl Estradiol tablets USP...
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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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