Generics Industry News Search
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December 2005 News Archive |
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Par Pharmaceutical Companies, Inc. announced that the U.S. Food and Drug Administration (FDA) granted tentative approval for the company's Abbreviated New Drug Application (ANDA) for cabergoline tablets. ...
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Barr Pharmaceuticals, Inc., Organon USA Inc. and Organon (Ireland) Ltd., business units of Akzo Nobel NV, and Savient Pharmaceuticals, Inc. today announced that Barr and its subsidiaries have finalized an agreement to acquire the exclusive rights to Organon's Mircette(R) (Desogestrel/Ethinyl Estradiol) ...
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The Federal Trade Commission has notified Teva Pharmaceutical Industries Ltd. and Wyeth that it will not file an objection with the United States District Court for the District of New Jersey to the proposed settlement of the patent litigation between Teva and Wyeth concerning Teva’s application to market an extended release venlafaxine capsule product....
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Par Pharmaceutical Companies, Inc. today announced that its marketing partner, Three Rivers Pharmaceuticals, has received final approval by the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for ribavirin...
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IMPAX laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application for a generic version of OxyContin(R) (Oxycodone Hydrochloride) ...
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Eisai Co., Ltd. and Eisai Inc. today announce the filing of a patent infringement lawsuit against Teva regarding its submission of an abbreviated new drug application (ANDA) to the FDA for Aricept® (donepezil hydrochloride). Eisai's action was filed in the U.S. District Court for the District of New Jersey in Newark.
Eisai believes that its donepezil composition of matter patent is valid until its expiration date of November 25, 2010. Eisai intends to vigorously enforce and defend that patent....
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Alpharma Inc., a leading global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration has granted tentative approval for the company’s ANDA for sertraline hydrochloride 25 mg, 50 mg, and 100 mg tablets....
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The World Trade Organization (WTO) members approved measures to make it easier for developing countries to get cheaper generic versions of medicines for communicable diseases like AIDS. ...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company’s ANDAs for Cefprozil Tablets USP, 250 mg and 500 mg and Cefprozil for Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL....
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Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. announced today that they have entered into an agreement with Cephalon, Inc. to settle their pending patent infringement disputes in the United States and the United Kingdom related to PROVIGIL® (modafinil) Tablets [C-IV]....
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Doxycycline Monohydrate ...
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Actavis announces that it has been among the first to launch the generic drug Glimepiride, into a number of important markets in Europe. Glimepiride is the generic equivalent of Amaryl/Amarel a product of Aventis. ...
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Baxter Healthcare Corporation announced today the launch of sevoflurane, the world's most widely-used inhaled anesthetic, in China. The company also unveiled its plans for a phased launch of sevoflurane in additional geographies throughout 2006,...
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Bentley Pharmaceuticals, Inc., a technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe, announced today that it has received approvals of generic versions of its lansoprazole formulations ...
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Caraco Pharmaceutical Laboratories, Ltd. announced today that the US Food and Drug Administration have granted an FDA approval for the Company's ANDA for Carbamazepine 200mg USP. In addition the FDA granted approval on 100mg, 300mg and 400mg, ...
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Akorn, Inc. today announced that it has signed a Letter of Intent with Azad Pharma AG, located in Toffen Switzerland, to develop and supply three ANDA injectable drug products for critical care medicine....
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Glenmark Pharmaceuticals Ltd. and InvaGen Pharmaceuticals, Inc. have entered into a collaboration agreement for the joint development, filing and marketing of seven generic pharmaceutical products for the US market....
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American Pharmaceutical Partners, (APP), a leading manufacturer of sterile injectable generic drugs for the U.S. and Canada, and Technoflex S.A. of France, a leading supplier of polypropylene and PVC bags and closures to the global pharmaceutical industry, are forming a joint venture to manufacture sterile-filled injectable drugs at APP's Grand Island, N.Y. facility. ...
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Ranbaxy Laboratories Limited announced today that the U.S. District Court of Delaware ruled against Ranbaxy in its case for non-infringement and invalidation of two Pfizer patents on atorvastatin. Atorvastatin is a cholesterol-lowering drug, marketed by Pfizer as Lipitor ® , and is the largest-selling drug in the world....
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Allergan Inc. announced today that it has filed a motion with the United States District Court for the Northern District of California, San Francisco Division, requesting a temporary restraining order and preliminary injunction prohibiting the sale of a proposed generic version of Allergan's non-steroidal anti-inflammatory drug ACULAR(R) (ketorolac tromethamine ophthalmic solution) 0.5% while the court conducts further proceedings in a patent infringement lawsuit brought by Allergan and Syntex (U.S.A.) LLC against Apotex, Inc., Apotex Corp., and Novex Pharma Inc. ...
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Par Pharmaceutical Companies, Inc. today announced that it has been assigned Ivax Corporation's U.S. distribution rights for various dosage forms of the immediate release antibiotics amoxicillin/clavulanate potassium and amoxicillin. ...
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Akorn, Inc. today announced that it has signed a Letter of Intent with Natco Pharma Limited, located in Hyderabad, India, to develop and supply two ANDA oral tablet drug products for cancer patients suffering from nausea and vomiting....
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Bellwether Pharma Limited announced a major coup by launching its new brand of loratadine into the generic antihistamine market. Bellwether’s Lorastyne, comes into the market eight months prior to the loratadine patent expiry. ...
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Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) have granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride with Acetaminophen Tablets.
Caraco's Tramadol Hydrochloride (HCl) with Acetaminophen Tablets is the generic equivalent of Ortho-McNeil Pharmaceutical Inc. brand product, Ultracet(R), which is indicated for the short-term (five days or less) management of acute pain.
We are extremely pleased on receiving this approval and plan to launch this product to the market immediately, said Daniel H. Movens, Chief Executive Officer. This approval brings our total product portfolio to 19 different products represented by 41 strengths.
On September 22, 2004, Ortho-McNeil Pharmaceutical, Inc. (Ortho-McNeil) filed a complaint in the United States District Court for the Eastern District of Michigan alleging that the Company's filing of an ANDA seeking approval to market its generic version of Ortho-McNeil's Ultracet(R) drug product infringed Ortho-McNeil's patent, which expires on September 6, 2011. Ortho- McNeil sought an order from the Court which, among other things, directed the FDA not to approve Caraco's ANDA any earlier than the claimed expiration date. The ANDA filed by Caraco contained a Paragraph IV Certification challenging the Ortho-McNeil patent. On October 19, 2005 our motion for summary judgment was granted. Ortho-McNeil has the right to appeal....
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Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bisoprolol Fumarate Tablets USP, 5mg and 10mg. Bisoprolol Fumarate Tablets,...
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Xechem International, Inc. announced today that it has settled its antitrust lawsuit against Bristol-Meyers Squibb Co. for $4.2 million. Court files reveal that the case against Bristol-Meyers, which was brought in federal district court in Chicago in 2003, ...
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Pfizer Inc announced today that a Spanish court is the latest judicial body to uphold the company's patents covering the active ingredient in Lipitor, the world's most-prescribed cholesterol-lowering medication....
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Andrx Corporation announced today that it has filed a patent infringement lawsuit in the U.S. District Court for the Southern District of Florida against GlaxoSmithKline plc and SmithKline Beecham Corporation. ...
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Mylan Laboratories Inc. announced today that its subsidiary, Mylan Pharmaceuticals Inc., has entered into two agreements with Ortho-McNeil Pharmaceutical, Inc. and Alza Corporation relating to oxybutynin chloride extended release tablets,...
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Elite Pharmaceuticals, Inc. announced today that it had entered into an amendment with its partner, IntelliPharmaCeutics Corp., under the Product Development and Commercialization Agreement, dated as of June 21, 2005. ...
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The Food and Drug Administration (FDA) today announced the tentative approval of Stavudine for Oral Solution, 1 mg/mL to be manufactured by Aurobindo Pharma LTD. of Hyderabad, India. This product is the first generic version of the already approved Zerit for oral solution manufactured by Bristol-Myers Squibb. ...
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Baclofen 20mg tablets....
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Ranbaxy Laboratories Limited announced today that it has entered into an agreement with Cephalon, Inc. to settle their pending patent infringement dispute in the United States related to PROVIGIL(R) (modafinil) Tablets [C-IV]....
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Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zonisamide Capsules, 25 mg, 50 mg, and 100 mg. Zonisamide Capsules are the AB-rated generic equivalent of Dainippon Pharmaceutical's Zonegran® Capsules, which had U.S. sales of approximately $171 million for the 12-month period ending June 30, 2005, according to IMS Health....
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Daiichi Sankyo has announced that its wholly owned subsidiary Daiichi Pharmaceutical has won the lawsuit against Mylan Pharmaceuticals. ...
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The Food and Drug Administration (FDA), on December 27, 2005, granted tentative approval, through an expedited procedure, to generic Nevirapine Oral Suspension, 50 mg/5 mL, manufactured by Aurobindo Pharma LTD., of Hyderabad, India. ...
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Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for the company's Abbreviated New Drug Application for cabergoline tablets. ...
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Taro Pharmaceutical Industries Ltd. reported today that it has entered into an agreement with Alkem Laboratories Ltd. under which the companies will develop products jointly for the U.S. and other markets. ...
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