Generics Industry News Search
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September 2012 News Archive |
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Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 100 mg, 150 mg and 200 mg 12-hr extended release tablets of Bupropion HCl which is used in the treatment of depression...
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Impax Laboratories today announced that it has reached agreement with Genzyme, a Sanofi company, to settle pending U.S. litigation with regard to the production and sale of generic formulations of RENVELA (sevelamer carbonate 800 mg tablet and oral suspension 2.4g and 0.8g) and RENAGEL (sevelamer hydrochloride 400 mg and 800 mg tablets)....
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Validity of certain patent claims covering Zegerid capsule and powder upheld...
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Teva Pharmaceutical Industries, a generic pharmaceutical company, has announced that the UK High Court of Justice issued a decision in favor of Teva in a patent litigation proceeding against Generics, UK, Limited, a subsidiary of Mylan Laboratories....
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Perrigo announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Albuterol sulfate HFA inhalation aerosol, the generic version of ProAir HFA....
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Shire plc announces that its subsidiary, Shire LLC, has settled all pending litigation with Anchen Pharmaceuticals and Anchen and TWi Pharmaceuticals in connection with TWi's Abbreviated New Drug Application (ANDA) for a generic version of Shire's Intuniv (Guanfacine hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder...
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Mylan today announced that it and its subsidiary, Mylan Pharmaceuticals, have entered into a settlement agreement with Pfizer, Pharmacia & Upjohn Company LLC and Pfizer Health AB that will resolve the parties' patent litigation in connection with Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Tolterodine tartrate ER capsules, 2 mg and 4 mg, which is the generic version of Pfizer's Detrol LA, indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency...
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A unit of Teva Pharmaceutical (TEVA), the world's largest maker of generic drugs, sued rival Perrigo (PRGO) over patents for the ProAir asthma inhaler...
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Teva Pharmaceutical Industries announces the launch of generic Tolterodine 1mg and 2mg film-coated tablets, and Tolterodine XL (Mariosea XL) 4mg capsules....
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Osmotica Pharmaceutical today announced the execution of a strategic alliance agreement between Panacea Biotec and Osmotica for the research, development and commercialisation of brand and generic products in the United States and key strategic markets across the globe....
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Dr. Reddy's Laboratories announced today that it has launched Metoprolol succinate ER (Extended-Release) Tablets (25 mg, 50 mg, 100 mg & 200 mg), a bioequivalent generic version of Toprol-XL (Metoprolol succinate) tablets, in the US market on September 11, 2012....
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Impax Laboratories today announced that it and Teva Pharmaceuticals USA have reached agreement with Janssen Pharmaceuticals and ALZA Corporation (together, ALZA) to settle pending U.S. litigation with regard to the production and sale of generic formulations of Concerta (Methylphenidate hydrochloride extended release tablets, 18 mg, 27 mg, 36 mg, and 54 mg)...
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Lannett Company (LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophen and Caffeine tablets, USP, 50mg/325mg/40mg...
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Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 15 mg and 30 mg delayed release capsules of Lansoprazole, which is used in treatment of peptic ulcers...
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The In re K-Dur Antitrust Litigation case (formally, Louisiana Wholesale Drug Co. et al. v. Merck & Co. and Upsher-Smith Laboratories, Inc.) is significant because, for the first time in almost a decade, the Federal Trade Commission succeeded in convincing a U.S. Circuit Court of Appeals (here, the Third Circuit) that there was merit in its argument that "reverse payment" agreements between branded and generic drugmakers in ANDA litigation under the Hatch-Waxman Act constitutes a per se restraint on trade and should incur antitrust liability. ...
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Jazz Pharmaceuticals climbed to its highest value ever after winning a federal judge's support in a patent dispute over its best-selling medicine Xyrem to treat narcolepsy...
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In what could be a definitive step towards ensuring availability of affordable drugs to the patients, India's Intellectual Property Appellate Board (IPAB) yesterday rejected the German drug major Bayer's request for a stay order against the grant of compulsory license on its anti-cancer drug Nexavar to Natco Pharma....
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Glenmark Pharmaceuticals has received tentative approval from the US health regulator for its generic Rizatriptan benzoate tablets used for treating migraine attacks...
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A patent dispute between Actavis Group HF and Paris-based Sanofi (SAN) over a drug to treat diabetes and hypertension was referred to a European Union court by a London judge...
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Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Valsartan and Hydrochlorothiazide tablets...
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Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Meclizine hydrochloride tablets...
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Depomed today announced that it has filed an action in federal district court for the District of Columbia against the Food and Drug Administration, seeking an order requiring the FDA to grant Gralise (Gabapentin) Orphan Drug exclusivity for the management of postherpetic neuralgia (PHN)....
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Endo Pharmaceuticals a subsidiary of Endo Health Solutions announced today that the company has received Paragraph IV Certification Notices from Teva Pharmaceuticals and Amneal Pharmaceuticals each advising of the filing of Abbreviated New Drug Applications (ANDAs) for generic versions of OPANA (Oxymorphone HCl)....
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In a case decided Monday by a federal jury in Worcester, Johnson & Johnson won its challenge to two Abbott Laboratories patents on antibodies that help curb the effects of the painful skin disease psoriasis....
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Provincial health ministers are calling on Ottawa to delay the approval of a generic form of OxyContin....
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Dr. Reddy's Laboratories announced today that it has launched Montelukast sodium oral granules....
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Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Irbesartan tablets USP, 75 mg, 150 mg and 300 mg, the generic version of Sanofi's Avapro....
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