Generics Industry News Search
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November 2006 News Archive |
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ROCKVILLE, Md., Nov. 1, 2006-The Food and Drug Administration today approved the first generic version of MetroGel-Vaginal (metronidazole vaginal gel), a treatment for bacterial vaginosis. ...
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Judge Ann D. Montgomery of the U.S. District Court for the District of Minnesota recently granted Paddock Labs' motion for summary judgment of noninfringement of Warner-Lambert's U.S. Patent No. 4,743,450, which covers pharmaceutical formulations of moexipril hydrochloride, the active ingredient in Univasc...
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PRINCETON, N.J., November 02, 2006 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Syrup, 5 mg/5 ml. ...
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CAMBRIDGE, England, Nov. 2, 2006 - Mundipharma International Ltd announces a strengthening of its position with respect to European patents on its leading product, OxyContin® (oxycodone HCl controlled-release) tablets, following an agreement between Purdue Pharma L.P. and its associated companies and Teva Pharmaceuticals that has led to the withdrawal by Teva Pharmaceuticals Europe B.V....
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HAYWARD, Calif.--(BUSINESS WIRE)--Nov 3, 2006 - IMPAX Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Applications ...
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Merck Sharp & Dohme has won an injunction against GenRx that could hold off further competition and a price cut for its big-selling osteoporosis drug, Fosamax well into next year. For full details on the case please click on the link below....
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Glipizide ER tablets are used to treat type 2 diabetes in patients, particularly in people whose diabetes cannot be controlled through diet alone. Glipizide ER tablets are the authorized generic product of Pfizer's Glucotrol XL® tablets. ...
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Company Also Receives Tentative ANDA Approval for Cetirizine Syrup, Generic Equivalent to Zyrtec
HAWTHORNE, N.Y., Nov. 8, 2006 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Meloxicam Tablets, 7.5 mg and 15 mg (meloxicam tablets)....
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PITTSBURGH, November 08, 2006 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA)...
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TORONTO, ONTARIO--(CCNMatthews - Nov. 8, 2006) - Orbus Pharma Inc. today announced that it has entered into an exclusive license, supply and distribution agreement with Gennium Pharma Inc. (Gennium) of Mississauga, Ontario, to supply a generic cephalosporin to the Canadian market....
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The Federal Circuit today reversed a district court decision that upheld the validity of Abbott's U.S. Patent No. 5,990,176, finding instead that Abbott's patent is inherently anticipated by U.S. Patent No. 5,684,211....
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WOODCLIFF LAKE, N.J., November 09, 2006 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly and Company's ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg....
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COPENHAGEN, Denmark, Nov. 9, 2006--In 2003, Forest Laboratories, Inc. and H. Lundbeck A/S filed suit against Ivax Pharmaceuticals, Inc, now Teva Pharmaceuticals (Teva), for patent infringement related to Lexapro patent. ...
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NORTH WALES, Pa., Nov. 10, 2006 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Oxybutynin Chloride Extended-Release Tablets. This product is AB rated and bioequivalent to Ditropan XL®* Extended-Release Tablets. Oxybutynin Chloride Extended-Release Tablets are available in 15 mg strength, in a bottle size of 100 tablets....
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HAYWARD, Calif.--(BUSINESS WIRE)--Nov 10, 2006 - IMPAX Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) ...
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PITTSBURGH, November 10, 2006 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Applications...
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BASINGSTOKE, England and PHILADELPHIA, Pennsylvania, November 10, 2006 /PRNewswire-FirstCall/ -- Shire plc announces that its subsidiary Shire Laboratories Inc. has filed lawsuits in the US District Court for the District of New Jersey ...
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HAWTHORNE, N.Y.--(BUSINESS WIRE)--Nov 13, 2006 - Taro Pharmaceutical Industries Ltd. reported today that Taro Pharmaceuticals (UK) Limited (Taro UK), its affiliate in the United Kingdom, has been granted a marketing authorization for Etopan XL Tablets 600 mg, Etodolac (Etopan XL) by the Medicines and Healthcare Products Regulatory Agency, the UK equivalent of the U.S. Food and Drug Administration. ...
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The Court of Appeals for the D.C. Circuit today affirmed a district court decision finding that the FDA wrongly delisted two Merck patents on Zocor (simvastatin), which in turn unlawfully denied Teva and Ranbaxy from 180 days of marketing exclusivity on generic simvastatin....
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COVINGTON, Ky.--(BUSINESS WIRE)--Nov 14, 2006 - Omnicare, Inc., the nation's leading provider of pharmaceutical care for the elderly, today said that it has reached a voluntary civil settlement with the federal government and 42 states related to a previously disclosed review of three generic pharmaceuticals provided by the Company in connection with the substitution of capsules for tablets (Ranitidine), ...
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ROCKVILLE, Md., Nov. 17, 2006-On November 17, 2006, the Food and Drug Administration (FDA) granted tentative approval for a new fixed drug combination of stavudine/lamivudine/nevirapine...
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MELVILLE, N.Y., Nov. 17 /PRNewswire/ -- Specialty pharmaceutical manufacturer Fougera, a division of ALTANA Inc, announced today that it has received FDA approval to bring to market the first generic Sulfacetamide Sodium Topical Suspension ...
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Australian-based Mayne Pharma has lost a patent infringement lawsuit in the U.S. Court of Appeals for the Federal Circuit for an anesthetic drug Propofol, which upholds a U.S. District Court for the Southern District of New York decision finding that Mayne’s injectable formulation of propofol infringed patents held by AstraZeneca....
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-- Collaboration Expected to Result in One of the First Introductions of a Biosimilar Erythropoietin in Europe --
LAKE FOREST, Ill., Nov. 20, 2006 -- Hospira, a leading global hospital products company,...
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Purchase of majority stake in Russian manufacturing facility strengthens position in fast growing market.
Actavis announced today that it has acquired a 51% controlling interest in ZiO Zdorovje, a leading Russian pharmaceutical manufacturer....
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JERUSALEM, Israel--(BUSINESS WIRE)--Nov 22, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Applications (ANDAs) for Ondansetron Injection USP, 2 mg/mL, packaged in 4 mg/2 mL single-dose vials, ...
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AstraZeneca today announced it has entered into a supply and distribution agreement with Par Pharmaceutical to distribute an authorized generic version of metoprolol succinate in the United States. Currently, the authorized generic product will be distributed in the 25 mg dosage strength. ...
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HAYWARD, Calif.--(BUSINESS WIRE)--Nov. 22, 2006--IMPAX Laboratories, Inc. today announced that the United States Court of Appeals for the Federal Circuit ruled that the district court had erred in deciding, after trial,...
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LOS ANGELES--(BUSINESS WIRE)--Nov 28, 2006 - Abraxis BioScience, Inc., an integrated, global biopharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for the combination drug Ampicillin and Sulbactam for Injection, 15g, USP, the generic equivalent of Pfizer Inc.'s Unasyn(R). ...
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Earlier, the Court of Appeals for the Federal Circuit affirmed a District Court's decision that Transkaryotic Therapies Inc. (TKT) and Aventis Pharmaceuticals Inc. infringe Amgen's erythropoietin (EPO) patent estate. Amgen Inc., v. Hoechst Marion Roussel, Inc. (Now Aventis) and Transkaryotic Therapies, Inc., (05-1157). ...
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WOODCLIFF LAKE, N.J., November 28, 2006 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. and its subsidiary PLIVA d.d. today announced that PLIVA has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market Pravastatin Tablets 10mg, 20mg, and 40mg, the generic version of Bristol-Myers Squibb's PRAVACHOL(R) (Pravastatin Sodium) Tablets....
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November 29, 2006, Hyderabad & Ahmedabad, India: Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) and Torrent Pharmaceuticals Ltd. today announced that they have concluded an agreement for exclusive commercialization of two of Torrent’s brands in Russia, viz. Listril (Lisinopril) and Listril Plus (Lisinopril HCTZ),...
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JERUSALEM--(BUSINESS WIRE)--Nov 29, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application...
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Akorn, Inc. today announced that the U.S. Food and Drug Administration has granted tentative approval for Akorn's Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Ophthalmic Solution 0.1% in 2.5 ml and 5 ml dropper bottles. Final approval is expected upon expiry of patent protection for Voltaren® Ophthalmic Solution 0.1% in October 2007....
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Acquisition gives Actavis a strong foothold in high value Controlled Release market...
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