Generics Industry News Search
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June 2005 News Archive |
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BEDFORD, OH – June 1, 2005 – Bedford Laboratories™, a division of Ben Venue Laboratories, Inc., announced today that it received FDA approval for Propofol Injectable Emulsion, 1%. The product is equivalent to Diprivan® from AstraZeneca, an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation....
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MIAMI – June 1, 2005 – IVAX Corporation (AMEX: IVX, LSE: IVX.L, WSE: IVX) has received a final approval from the U.S. Drug and Food Administration (FDA) for its Abbreviated New Drug Application (ANDA) for clarithromycin tablets USP, 250 mg and 500 mg....
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Jerusalem, Israel, June 1, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company’s ANDA for Clarithromycin Tablets USP, 250 mg and 500 mg. A launch date has not yet been determined....
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Cranbury, NJ, May 6, 2005 – Able Laboratories, Inc. (NASDAQ: ABRX) and InvaGen Inc. today announced the signing of an exclusive Development Agreement for generic pharmaceutical products utilizing InvaGen’s expertise in pharmaceutical development....
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MIAMI – June 6, 2005 – IVAX Corporation, commenting upon the U.S. District Court for the District of Northern Illinois decision to grant Abbott Laboratories Inc.’s motion for a preliminary injunction against sales by Teva Pharmaceutical Industries Ltd. ...
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Jerusalem, Israel, June 5, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Northern Illinois has granted Abbott’s motion for a preliminary injunction related to Teva’s generic Clarithromycin Extended Release Tablets pending a trial on the merits or further court order....
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US – June 7, 2005 – Shire Pharmaceuticals Group plc remains committed to protecting the patents which it has relating to ADDERALL XR®, its product for treatment of Attention Deficit Hyperactivity Disorder (ADHD)....
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MIAMI – June 8, 2005 – IVAX Corporation announced today that its subsidiary, IVAX Pharmaceuticals, Inc., will distribute, in the United States, oxycodone HCl controlled release tablets C-II in 10, 20, 40 and 80 mg dosage strengths, supplied by Purdue Pharma L.P. of Stamford, Connecticut. ...
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Ranbaxy Laboratories Limited (Ranbaxy), India’s largest pharmaceutical company, announced today that it has acquired a generic product portfolio accounting for eighteen products belonging to the Spanish pharmaceutical company EFARMES, S.A....
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Eon Labs, Inc. (Nasdaq: ELAB) announced today that the United States Court of Appeals for the Federal Circuit unanimously affirmed the judgment of the U.S. District Court for the Eastern District of New York that the Company's generic itraconazole product does not infringe Janssen Pharmaceutica N.V. and Janssen Pharmaceutica Products L.P.'s U.S. Patent No. 5,633,015....
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Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) announced today that it has received approval from the Office of Generic Drugs of the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) for carboplatin injection in 50 mg, 150 mg and 450 mg multi-dose vials....
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Barr Pharmaceuticals, Inc. today confirmed that Janssen Pharmaceutica Products, L.P. and Synaptech filed suit against the Company's subsidiary, Barr Laboratories, Inc., in the District Court of Delaware, relating to the patents protecting Razadyne(R) (Galantamine Hydrobromide), 4 mg, 8 mg and 12 mg Tablets, formerly Reminyl(R)....
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AstraZeneca announced today that it does not accept the European Commission’s decision that it infringed Article 82 EC during the marketing of Losec (omeprazole) in the 1990s, and will appeal the decision to fine the company 60 million Euros to the Courts....
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CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI) today announced that its motion seeking a temporary restraining order and a preliminary injunction in the United States District Court for the Eastern District of New York had been denied....
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Matrix Laboratories Ltd (Mumbai Stock Exchange, 524794; National Stock Exchange, MATRIXLABS), announced today that their Board of Directors have approved to acquire a controlling stake in Docpharma NV (Eurolist of Euronext Brussels, DOCPH), from Chairman and founder, Mr. Leon Van Rompay, and other key shareholders (the Reference Shareholders) for a price of EUR 34 per share....
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The Food and Drug Administration (FDA) today announced the tentative approval of two applications for nevirapine tablets manufactured by Ranbaxy Laboratories Limited, Guragon, India and Aurobindo Pharma Limited, Hyderabad, India. These are the first generic versions of Viramune Tablets manufactured by Boehringer Ingelheim....
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Aurobindo Pharma Limited has crossed one more milestone in its ARV (Anti-Retro Virals) filing with US FDA. Aurobindo has received tentative approval from US FDA for Nevirapine, a key ARV in the treatment of AIDS....
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Ranbaxy Laboratories Limited (RLL) announced today that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Terbinafine Hydrochloride Tablets, 250 mg....
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PHILADELPHIA, United States, June 17 (Bernama) - Asean's 500 million population will have better access to expensive and hard-to-get bio-generic drugs once Innobiologics Sdn Bhd's bio-facility comes on stream in 2007, said its chief executive officer Dr Mohd Nazlee Kamal....
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Eon Labs, Inc. announced today that it received final approval for Bupropion HCl, ER 200mg tablets, the generic equivalent of Wellbutrin SR(R)* 200mg tablets. The Company will begin shipping immediately....
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Teva Pharmaceutical Industries Ltd. and H. Lundbeck A/S announced today that Azilect®, a once-daily treatment for Parkinson’s disease (PD) both as monotherapy in patients with early PD and as an adjunct treatment in moderate to advanced disease, is now available in the United Kingdom....
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Torrent Pharmaceuticals Ltd (TPL) today agreed to acquire Heumann Pharma GmbH & Co Generica KG (“Heumann Pharma Generics”) of Germany through its wholly owned German subsidiary, Torrent Pharma GmbH (TPG). ...
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Northvale, New Jersey, Tuesday, June 28, 2005: Elite Pharmaceuticals, Inc. (Amex: ELI) announced that it has entered into a product development and license agreement with Pliva, Inc. (East Hanover, NJ), a subsidiary of PLIVA d.d., a specialty generics pharmaceutical company, for a generic, controlled release drug product formulated by Elite. ...
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The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) today announced that it has received approval from the USFDA for its ANDA (Abbreviated New Drug Application) of Cephalexin capsules USP 250 mg and 500 mg. ...
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Alpharma Inc., a leading global generic pharmaceutical company, today announced that the U.S. Food and Drug Administration has granted final approval for the company’s ANDA for glyburide/metformin HCl Tablets in the following dosages: 1.25 mg/250 mg; 2.5 mg/500 mg; and 5 mg/500 mg....
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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S Food and Drug Administration has granted final approval for the company’s ANDA for Mirtazapine Orally Disintegrating Tablets (ODT), 15 mg, 30 mg and 45 mg....
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