Generics Industry News Search
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September 2014 News Archive |
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India's Cipla has launched an anti-asthma inhaler in Germany and Sweden that is a generic version of GlaxoSmithKline's Advair...
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Daiichi Sankyo today announced that its domestic generic drug subsidiary, Daiichi Sankyo Espha, obtained a manufacturing and marketing license in Japan on August 15, 2014 for Levofloxacin Tablets 250mg DSEP, 500mg DSEP and Granules 10% DSEP...
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Prosonix, an innovative speciality pharmaceutical company developing a portfolio of inhaled respiratory medicines by design, announces that its Marketing Authorisation Application for PSX1001...
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Under the auspices of the International Generic Drug Regulators Pilot, the TGA is participating in a pilot of the Decentralised Procedure of the EU...
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India's troubled Wockhardt is again expanding its voluntary recall of Metoprolol succinate extended-release tablets, a generic of AstraZeneca's hypertension drug Toprol XR...
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Guangzhou Baiyunshan Pharmaceutical has received the approval of the China FDA to manufacture its medicine for treating erectile dysfunction...
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Cancer drug major Fresenius Kabi Oncology, the Indian arm of Germany-based Fresenius Kabi, has withdrew revocation petitions against cancer drug patents owned by Pfizer...
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Teva today announces the launch of the generic equivalent to Baraclude (Entecavir) tablets...
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Mylan today announced that it has launched Ibandronate sodium injection...
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Attorney General George Jepsen has asked the U.S. FDA to take action that would speed the introduction of generic forms of the heartburn drug Nexium to the market...
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Gilead Sciences is close to a pact with generic drugmakers to bring low-cost versions of its $84,000 hepatitis C drug Sovaldi to about 80 developing countries including India, Indonesia, and Pakistan...
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Breckenridge Pharmaceutical announced today that it has filed an ANDA with a Paragraph IV certification for Everolimus oral tablets...
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Bristol-Myers Squibb and partner Ono Pharmaceutical have sued Merck, alleging that its new cancer drug violates their patent for a method of harnessing the body's immune system to fight cancer...
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Sagent today announced the launch of Ibandronate sodium injection...
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Depomed today announced that Judge Kentaji Brown Jackson of the federal district court for the District of Columbia has granted...
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Charting new territory in the multibillion-dollar market for medicines derived from living organisms, a federal appeals court for the first time will review the...
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Mylan commented on a ruling by the U.S. District Court for the District of Maryland related to its product, Dexmedetomidine hydrochloride injection, 100 mcg (base)/ml, packaged in 200 mcg (base)/2 ml Single-dose Vials...
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ACETO announced that Rising Pharmaceuticals, its finished dosage form generics subsidiary, has completed the purchase of three ANDAs from Par Pharmaceuticals acquiring Doxercalciferol...
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Par Pharmaceutical announced that it has resumed shipping Dexmedetomidine hydrochloride (HCl) injection, EQ 100 mcg base/ml, the generic version of Hospira's Precedex injection...
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Endo announced today that it has introduced the first and only generic 2% topical testosterone gel, an authorised generic of Fortesta gel (Testosterone gel) CIII...
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Nuvo Research, a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced that it has reached a full settlement with Mallinckrodt...
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The U.S. Federal Trade Commission sued drugmakers AbbVie and Teva Pharmaceuticals USA on Monday in federal court in Philadelphia, alleging that they harmed consumers...
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Basel-headquartered Novartis Pharmaceuticals dragged Dr Reddy's Laboratories (DRL) to the US court over alleged patent infringement...
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Neos announced today that is has settled all pending litigation with Shire in connection with Neos' Amphetamine polistirex...
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Zydus Cadila is facing lawsuits in various US courts, including one filed by global pharma major Novartis Pharmaceuticals, for infringement of patents...
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Mylan today announced that its subsidiary Mylan Ireland Limited has entered into an agreement to acquire the U.S. commercialisation...
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Lannett company today announced that it has received approval from the U.S. FDA of its ANDA for Oxycodone hydrochloride oral solution USP, 100 mg per 5 ml...
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The copycat version of Sanofi's best-selling insulin makes it the fourth diabetes product approved in the EU under a Lilly-Boehringer alliance...
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Ranbaxy is facing increasing pressure from different states in the US, rival generic drugmakers...
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Pfizer and Ranbaxy Laboratories on Friday won dismissal of an antitrust lawsuit accusing them of conspiring to delay sales of generic versions of the cholesterol drug Lipitor, the best-selling drug in history...
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Gilead today announced that the company has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers...
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Allergan and Duke University won't have their patent suit for the Latisse eyelash drug reheard...
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Avanir's combinatorial approach to calming dementia-related outbursts among Alzheimer's patients...
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After months of skirmishes, the government is finally going to sit down with American pharma giants this week...
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Epirus, a Boston-based biopharmaceutical company focused on the global development and commercialisation of biosimilar monoclonal antibodies...
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Mylan today announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's Advair Diskus and its insulin analog to Sanofi's Lantus...
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While the Indian government is pushing generic drugs as they are cheaper and, therefore, more affordable, there seems to inadequate attention on ensuring that the quality protocol of these drugs is properly observed...
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Eagle Pharmaceuticals announced today that Cephalon, a subsidiary of Teva Pharmaceutical has moved to dismiss with prejudice its first lawsuit alleging that Eagle's tentatively approved...
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Aurobindo Pharm rallied as much as 3 per cent in trade on Wednesday after the pharm major said that...
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The US FDA has released two new guidance documents intended to clarify for generic drug makers the criteria by which the agency determines which applications it will...
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Fresh from writing off one of its top late-stage programs, Merck KGaA stepped up with a revised comeback plan today, detailing plans to invest about...
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A bill has been introduced in Congressmen that would end a practice that generic drug makers say is used by their brand-name rivals to thwart competition...
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The announcement last week that United States pharmaceutical giant Gilead would allow seven Indian companies to make a cheap, generic version of Sovaldi...
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Raleigh's Salix reached a patent settlement with generic drug company Par Pharmaceutical...
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Lannett today announced that it has commenced shipping its recently approved Oxycodone hydrochloride...
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Dr Reddy's and Aurobindo have been dragged to the US Court in separate instances allegedly for infringing patents...
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BioMarin today announced that a Paragraph IV certification notice letter...
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Actavis today confirmed that it has filed an ANDA with the U.S. FDA seeking approval to market Buprenorphine transdermal system...
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IGI Laboratories a New Jersey based specialty generic pharmaceutical company, today announced it has acquired the regulatory rights and related documents and records for 18 drug products from AstraZeneca...
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We are happy to launch Levalbuterol inhalation solution...
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A federal judge in Chicago dismissed racketeering claims in a lawsuit accusing Abbott and AbbVie...
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Teva today announced that a positive judgment has been given by the UK High Court in support of Teva's case against AstraZeneca relating to the validity of EP 1,085,877 covering the SMART (Single inhaler Maintenance And Reliever Therapy) indication for AstraZeneca's fixed dose formoterol/budesonide combination product, Symbicort...
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Although biosimilars, highly similar versions of living cell-based biologic medicines, have been widely available to European patients for close to a decade now, their pathway in the United States has not been equally successful...
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