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   November 2014 News Archive news archive  


02/11/2014  Cipla-Novartis patent row: DIPP looking into merit of case news archive
The Commerce and Industry Ministry is looking into the merit of Cipla's demand for revocation of patents of Novartis for respiratory drug Indacaterol...
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03/11/2014  Breckenridge announces approval of Quetiapine fumarate tablets news archive
Breckenridge announces the approval of Quetiapine fumarate tablets...
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03/11/2014  Lupin receives FDA approval for generic Celebrex capsules news archive
Lupin announced today that it has received final approval for its Celecoxib capsules...
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03/11/2014  IDT to acquire 23 more generic drugs news archive
IDT Australia has arranged to acquire a portfolio of 23 marketed generic drug products for up to US$18 million ($20.7 million)...
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04/11/2014  Amgen-Sandoz squabble over Neupogen copy could reshape biosim marketing news archive
The patent provisions of the Hatch-Waxman Act are familiar to both sides of the branded-generic fence by now...
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05/11/2014  Glenmark Generics receives final ANDA approval for Omeprazole DR capsules news archive
Glenmark Generics has been granted final approval for its ANDA from the U.S. FDA for Omeprazole delayed release capsules...
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05/11/2014  Mylan launches generic Loestrin 24 Fe news archive
Mylan today announced the U.S. launch of its Norethindrone acetate and Ethinyl oestradiol tablets USP, 1 mg/0.02 mg and Ferrous fumarate...
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05/11/2014  Ranbaxy receives approval from US FDA to market Fenofibrate capsules USP, 43 mg and 130 mg news archive
Ranbaxy Laboratories announced today that the company has received approval from the U.S. FDA to manufacture and market Fenofibrate capsules USP...
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05/11/2014  Hospira announces U.S. launch of generic Paricalcitol injection news archive
Hospira, the world's leading provider of injectable drugs and infusion technologies, today announced the launch of Paricalcitol injection...
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05/11/2014  Pfizer gets one more relief from IPAB news archive
In a relief to the US pharma major Pfizer, The Intellectual Property Appellate Board (IPAB) has set aside the Assistant Controller of Patents and Designs order, which rejected the Patent Application the pharma company for a drug Tofacitineb treating rheumatoid arthritis...
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06/11/2014  ANI Pharmaceuticals announces the launch of Methazolamide tablets USP news archive
ANI today announced the launch of Methazolamide...
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06/11/2014  Perrigo reinitiates shipments of Guaifenesin extended-release 600mg tablets news archive
Perrigo announced today that it has reinitiated shipments of Guaifenesin...
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06/11/2014  Dr Reddy's, Endo get FDA approval to launch generic Valcyte news archive
The U.S. FDA said it has granted final approval to Indian drugmaker Dr Reddy's Laboratories and U.S. firm Endo International to make cheaper copies of Roche Holding AG's antiviral Valcyte...
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06/11/2014  U.S. pulls approval for Ranbaxy copies of AstraZeneca and Roche drugs news archive
The U.S. FDA has revoked a tentative approval for India's Ranbaxy Laboratories to make a cheap copy of AstraZeneca's heartburn drug Nexium...
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10/11/2014  Ipsos healthcare launches Biosimilar Impact Study news archive
Ipsos Healthcare has announced the launch of its syndicated Biosimilar Impact Study...
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11/11/2014  Drug firm Venus Remedies gets nod to market generic Meropenem in Switzerland news archive
Drug firm Venus Remedies has received approval from the Swiss drug authority to market its generic injectable antibiotic Meropenem used for treating infections in the country...
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11/11/2014  Teva launches new generic Focalin XR news archive
Teva announced the availability of a new 5mg strength of Dexmethylphenidate HCl extended-release (ER) Capsules...
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12/11/2014  Lawsuit claiming infringement on Amitiza capsule patents news archive
Sucampo Pharmaceuticals announced that it, together with R-Tech Ueno, Sucampo AG, and Takeda and certain affiliates of Takeda, have filed a patent infringement lawsuit against Dr. Reddy's...
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12/11/2014  Horizon Pharma announces favorable Markman ruling in Rayos delayed-release tablets patent infringement Litigation news archive
Horizon today announced that a favorable Markman ruling has been issued...
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13/11/2014  Actavis in talks to acquire Allergan for over $60 billion news archive
Actavis is in talks to acquire Allergan for at least $60 billion, and striving to reach a deal that would help the Botox maker rebuff Valeant Pharmaceuticals' hostile advances...
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13/11/2014  AbbVie uses patents to ambush Gilead news archive
Chicago-based AbbVie and Foster City, California-based Gilead are trading lawsuits...
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13/11/2014  Mallinckrodt responds to FDA's expected reclassification of Methylphenidate ER news archive
Mallinckrodt has been informed by the FDA that the agency has reason to believe that the company's Methylphenidate hydrochloride...
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14/11/2014  Kremers Urban Pharmaceuticals informed by U.S. FDA of ANDA reclassification of methylphenidate ER news archive
Kremers Urban Pharmaceuticals (KU) has been informed by the U.S. FDA that the agency requests an additional bioequivalence study...
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14/11/2014  Can Amgen sue its way to the top of the PCSK9 pile? news archive
In the race to commercialise a new class of potential cardiovascular blockbusters, Amgen and its team of lawyers have filed a patent suit to fend off the advance of rivals Sanofi and Regeneron...
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17/11/2014  Teva Canada announces the launch of Teva-Celecoxib, a generic of Celebrex news archive
Teva Canada, announced today that Health Canada has approved its application for the generic version of Celebrex for the symptomatic relief associated with osteoarthritis...
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18/11/2014  Ranbaxy sues FDA over revoking approvals for Nexium, Valcyte copies news archive
Ranbaxy Laboratories has sued the U.S. FDA for revoking approvals granted to the Indian firm to launch copies of two drugs including AstraZeneca's heartburn pill Nexium, court documents showed...
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18/11/2014  Pfizer sues Mayne Pharm's US arm news archive
Australia-based drug giant, Mayne Pharm has reportedly filed an application seeking rights to produce and market the generic version of Pfizer's heart medication-Tikosyn...
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18/11/2014  India divided on whether to break Bristol-Myers drug patent news archive
The Indian government is divided about whether to break a patent on a Bristol-Myers Squibb cancer drug...
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18/11/2014  Sun Pharma recalls anti-depressant drug again news archive
Generic drug major Sun Pharma has recalled about 68,000 bottles of its anti-depressant Venlafaxine hydrochloride...
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18/11/2014  Vanc Pharmaceuticals receives Health Canada approval for 22 generic molecules news archive
Vanc Pharmaceuticals is pleased to announce that it has received Notice of Compliance...
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18/11/2014  STADA and mAbxience enter into negotiations over Adalimumab biosimilar news archive
STADA Arzneimittel AG and the biotech specialist mAbxience have agreed to negotiate over the in-licensing of an Adalimumab (Humira) biosimilar
...
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18/11/2014  FDA delays final rule on allowing generic drug makers to update labels news archive
A controversial new rule for updating generic drug labelling that the FDA was expected to finalise next month will not be published until the fall of 2015...
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19/11/2014  Mallinckrodt responds to FDA reclassification of Methylphenidate ER news archive
Mallinckrodt confirmed that on November 17, 2014 it filed a lawsuit against the FDA...
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20/11/2014  Ranbaxy loses bid to block rivals in generic drugs fight news archive
Ranbaxy Laboratories lost a bid for a temporary court order to block rivals' generic versions of the heartburn pill Nexium and the antiviral drug Valcyte...
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20/11/2014  Dr. Reddy's announces the launch of over-the-counter Fexofenadine hydrochloride 60 mg and Pseudoephedrine hydrochloride 120 mg extended-release tablets news archive
Dr. Reddy's Laboratories announced today that it has launched its over-the-counter (OTC) Fexofenadine hydrochloride and Pseudoephedrine hydrochloride extended release tablets 60 mg / 120 mg...
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20/11/2014  Endo announces launch of generic version of Valcyte news archive
Endo International today announced that its Qualitest subsidiary has launched a generic version of Hoffmann-La Roche's Valcyte...
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20/11/2014  Intellipharmaceutics notes launch of 5mg strength of Focalin XR generic by Teva news archive
Intellipharmaceutics a pharmaceutical company specialising in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs...
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21/11/2014  Supernus sues Zydus for infringement of Trokendi XR patents news archive
Supernus Pharmaceuticals, announced that it sued generic drug makers Zydus Pharmaceuticals and Cadila Healthcare for infringement of three patents covering its antiepileptic drug Trokendi XR...
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24/11/2014  Perrigo confirms first to file patent challenge for generic version of Aveed injection news archive
Perrigo today announced that it has filed with the FDA an ANDA for Testosterone undecanoate injection...
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24/11/2014  Perrigo announces the launch of a generic version of Astellas' Protopic ointment news archive
Perrigo today announced that it has agreed to market the authorised generic version of Astellas' Protopic ointmen...
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24/11/2014  Dr. Reddy's announces the launch of Docetaxel injection USP news archive
Dr. Reddy's announced today that it has launched Docetaxel injection...
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24/11/2014  IGI announces ANDA submission news archive
IGI today announced it has submitted an ANDA to the FDA...
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24/11/2014  U.S. court of appeals for the Federal circuit concurrently affirms denial of antares Pharm's motion to prohibit the marketing of Rasuvo news archive
Medac Pharm, today announced that it has filed a motion for a preliminary injunction against Antares Pharm, to prohibit sales of the 15, 20 and 25 mg doses...
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25/11/2014  Novartis announces extension to FDA review period for multiple myeloma investigational compound LBH589 news archive
Novartis announced today that the US FDA has extended their priority review period by up to three months for the new drug application (NDA) of LBH589 (Panobinostat) in combination with Bortezomib and Dexamethasone for patients with previously treated multiple myeloma...
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25/11/2014  Mylan confirms first-to-file patent challenge relating to Brevibloc news archive
Mylan today confirmed that it and several subsidiaries have been sued by Baxter, in connection with the filing of an ANDA with the U.S. FDA for Esmolol HCl in sodium chloride injection...
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25/11/2014  Mallinckrodt responds to court decision news archive
Mallinckrodt said today that the U.S. District Court for the District of Maryland, Greenbelt Division, has denied its motion for a temporary restraining order against...
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26/11/2014  VIVUS announces issuance of two additional U.S. patents for Qsymia news archive
VIVUS today announced that the U.S. PTO has issued U.S. Patent Nos. 8,895,057, covering methods for effecting weight loss using Qsymia, and 8,895,058, covering compositions of Qsymia...
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26/11/2014  US court refuses Ranbaxy appeal to block ANDA nod for 2 drugs news archive
Drug firm Ranbaxy Laboratories today said the DC Federal Court in the US has not granted the company temporary restraining order to block the US health regulator from approving...
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26/11/2014  IntelGenx announces update to settlement of U.S. patent litigation related to Forfivo XL news archive
IntelGenx today announced that it has settled its Paragraph IV litigation with Wockhardt Bio related to...
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28/11/2014  Nippon Kayaku launches Infliximab BS for I.V. infusion 100 mg in Japan news archive
Nippon Kayaku today launches the sale of Infliximab BS for I.V. Infusion...
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