Generics Industry News Search
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March 2006 News Archive |
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Aurobindo Pharma Ltd is pleased to announce that U.S. Food Drug Administration (US FDA ) has approved its Lisinopril Tablets 2.5, 5, 10, 20, 30 and 40 mg.
Lisinopril is an angiotensin converting enzyme (ACE) inhibitors are used for controlling blood pressure, treating heart failure and preventing kidney damage in people with hypertension or diabetes. They also benefit patients, who have had heart attacks....
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Aurobindo Pharma Ltd is pleased to announce that the US FDA has granted final approval for Aurobindo's Mirtazapine Orally Disintegrating Tablet (ODT) 45 mg....
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London Friday March 3, 2006- The generic cancer market was worth $1.3 billion in 2004*, however a new report by independent market analyst Datamonitor** (DTM.L) forecasts this market to reach $10.9 billion in value by 2014, achieving a compound annual growth rate (CAGR) of 24%. This staggering level of growth is attributable to upcoming patent expiries on key products, as well as the imminent introduction of a regulatory pathway for biogenerics, which will open up a previously untapped market that is currently worth billions. Despite the value of the market, for some, the perception of generics as being inferior to branded products remains....
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03 Mar 2006 - Basingstoke, UK and Philadelphia, US – March 3, 2006 – Shire plc announces that its subsidiary Shire Laboratories Inc. has filed a lawsuit in the US District Court for the Eastern District of Pennsylvania against Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. (‘Teva’) for infringement of Shire Laboratories’ US Patent Nos. 6,322,819 (‘the ‘819 Patent’) and 6,605,300 (‘the ‘300 Patent’)....
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Jerusalem, Israel,, March 6, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Topiramate Tablets, 50 mg....
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SPRING VALLEY, N.Y., March 7 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that it has resumed shipment of fluticasone propionate nasal spray, 50mcg., which is fully substitutable for GlaxoSmithKline's (GSK) Flonase. On February 23, Par halted all shipments in compliance with a temporary restraining order (TRO) granted to GSK by the U.S. District Court for the District of Maryland....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--March 7, 2006--Akorn, Inc. and Cipla, Ltd., a leading Indian pharmaceutical company located in Mumbai, India, today announced the signing of an exclusive drug manufacturing and supply agreement for an oral anti-infective ANDA drug product....
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HAYWARD, Calif., Mar 07, 2006 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) concerning its new drug application for Vadova(R) (carbidopa/levodopa) tablets. The letter cites several deficiencies in the application including observations resulting from an FDA inspection of the contract laboratory employed by IMPAX to perform bioequivalence studies....
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Allegan, Mich. - March 7, 2006 - The Perrigo Company announced that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Ciclopirox Olamine Cream USP, 0.77%....
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COLUMBUS, OH - March 7, 2006 - Roxane Laboratories, Inc. today announced that on March 6, 2006, the district court of Maryland denied GlaxoSmithKline's request to further extend the order temporarily suspending the U.S. Food and Drug Administration's (FDA) approval of Roxane Laboratories' Fluticasone Propionate Nasal Spray, 50mcg....
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WILMINGTON, Del., March 8 /PRNewswire-FirstCall/ -- AstraZeneca announced today that it has filed a lawsuit in the United States District Court for the District of New Jersey against IVAX Corporation, IVAX Pharmaceuticals, Inc. and Zenith Laboratories, Inc. (collectively IVAX), and IVAX's parent, Teva Pharmaceutical Industries Ltd. and its US subsidiary, Teva Pharmaceuticals USA, for willful infringement of AstraZeneca's patents protecting NEXIUM(R) (esomeprazole magnesium)....
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Recently, Philip Brooks sent me a note from one of the readers of his Patent Infringement Updates site. The note was regarding the generic challenge where a brand-name drug has recently gone generic and the drug manufacturer wishes to launch the product in a new indication. The reader asked if the manufacturer would be eligible for the three year market exclusivity extension for a new indication. Philip asked if I could post a response summarizing some of the particulars about the new indication extension....
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The opening round in a nest of cases surrounding the patent dispute between Lundbeck and Alphapharm over the anti-depressant Lexapro(R) (escitalopram oxalate) has resulted in a victory for the Australian generic company. Lundbeck was seeking relief to prevent the Commissioner of Patents from ammending the extension term of Australian Patent No. 623144. Lundbeck's application was dismissed and other related cases surrounding Lexapro is ongoing....
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An almost unknown Australian company has won a court victory that threatens to shorten the Australian patent life of Norvasc(R) (amlodipine besylate), Pfizer's top-selling anti-hypertensive. Spirit Pharmaceuticals have been joined to the proceedings in the Pfizer Corp vs Commissioner of Patents case which could reduce the extension term of Australian Patent No. 540769 from 26/02/2008 to 14/04/2007....
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Generic medicines company Genepharm Australasia has received marketing authorisation approval from the Therapeutic Goods Administration (TGA) to sell the first two of its anti-cancer injectable drugs in Australia.
The approved drugs, Epirubicin and Carboplatin, are two of the leading drugs used in Australian hospitals for the treatment of cancer....
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IRVINE, Calif., Mar 09, 2006 (BUSINESS WIRE) -- Allergan, Inc. announced today that Allergan and Alcon, Inc. have settled Allergan's patent infringement lawsuit in the United States District Court for the District of Delaware contending that Alcon's proposed brimonidine 0.15% product infringes two brimonidine-related patents owned by Allergan....
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SCHAUMBURG, Ill., March 9 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc., today announced that it has received two tentative approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Injection, USP, single-dose and multiple-dose vials, the generic equivalent of GlaxoSmithKline's Zofran(R) Injection....
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Philadelphia, PA, US and Basingstoke, UK – March 10, 2006 -- Shire plc announced today that in the pending New York litigation between Shire and Barr Laboratories, Inc. involving alleged infringement of U.S. Patent Nos. 6,322,819 and 6,605,300, the Court in a pretrial conference scheduled the bench trial to commence on October 30, 2006....
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Schering AG, Germany confirmed today that it has been informed by Merck KGaA representatives during the weekend that Merck KGaA intends to make an all-cash offer for the shares of Schering AG at EUR 77 per share....
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Gurgaon, Haryana, India - Ranbaxy Laboratories Limited, India, today announced entering into a strategic alliance with Zenotech Laboratories Limited, India. Under the semi-exclusive agreement, Ranbaxy will market Zenotech’s oncology cytotoxic injectable products under the Ranbaxy label, leveraging its global marketing and distribution network, in the key markets of Latin America (LATAM), including Brazil & Mexico, Russia and other CIS markets....
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CORONA, Calif., March 13 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. today announced a definitive merger agreement to acquire all outstanding shares of common stock of Andrx Corporation in an all-cash transaction for $25.00 per share, or a total price of approximately $1.9 billion. Andrx, whose capabilities complement those of Watson, is considered a leader in formulating difficult-to-replicate products and developing 'best-in-class' drug delivery technologies, offering a unique portfolio of difficult-to-replicate generic products....
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IRVINE, Calif., March 13 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. announced that it has filed its thirteenth Abbreviated New Drug Application (ANDA), which is for an injectable drug, with the U.S. Food and Drug Administration (FDA)....
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Perth-based pharmaceutical group PharmAust Ltd has been granted a licence to manufacture medicinal products by the Therapeutic Goods Administration (TGA) and aims to register and manufacture 50 low cost generic medicines by 2008....
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HAWTHORNE, N.Y.--(BUSINESS WIRE)--March 15, 2006--Taro Pharmaceutical Industries Ltd. reported today that Taro Pharmaceuticals U.S.A., Inc., its U.S. affiliate, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Mometasone Furoate Topical Solution USP, 0.1% (Lotion) (mometasone lotion)....
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JERUSALEM--(BUSINESS WIRE)--Mar 16, 2006 - Teva Pharmaceutical Industries Ltd. announced today that United States Court of Appeals for the District of Columbia has vacated the FDA's determination that Teva's exclusivity on pravastatin 10, 20, and 40 mg had been triggered and remanded the matter back to the FDA for further decision-making....
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Reykjavik, Iceland, 17 March 2006 - Actavis Group today announces that it has submitted a preliminary proposal to the management of PLIVA (PLIVA, the Croatian generic pharmaceuticals company, to acquire all the outstanding PLIVA shares on the Zagreb Stock Exchange and all the PLIVA GDRs on the London Stock Exchange....
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Actavis Ltd., located in Bulebel, has launched Glimepiride in Malta. Glimepiride is indicated for the treatment of diabetes, where the increased blood glucose cannot be adequately controlled by diet, physical exercise and weight reduction....
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Allegan, Mich. - March 21, 2006 - The Perrigo Company announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market terconazole vaginal suppositories, 80mg....
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HAWTHORNE, N.Y., Mar 23, 2006 (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. reported today that its U.S. affiliate has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Terbinafine Hydrochloride Cream 1% (terbinafine cream)....
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Pfizer Grants Baxter Exclusive Authorized Generic for Commonly Used Antibiotic
DEERFIELD, Ill., March 23, 2006 – Baxter Healthcare Corporation today announced the launch of generic azithromycin for injection (Pfizer/Zithromax®), a commonly used antibiotic. The launch marks the first time Baxter has been granted exclusive authorization by a pharmaceutical company to market a generic version of their brand product. Pfizer will manufacture generic azithromycin for injection and Baxter will sell and market the product in the United States....
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Gurgaon, Haryana, India, March 27, 2006 - Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, and among the top ten generic pharmaceutical companies in the world, announced today that the Company will acquire, the unbranded generic business of Allen S.p.A, a division of GlaxoSmithKline (GSK), in Italy, through Ranbaxy’s Italian subsidiary, Ranbaxy Italia S.p.A.. The deal will come into effect from April 01, 2006....
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Sanofi-Aventis has acquired a 24.876% stake in Zentiva via the purchase of a 19.634% stake from Warburg Pincus, a 4.507% stake from the management and employees of Zentiva and a 0.734% stake from certain former managers of Zentiva. Today’s deal delivers a long-term relationship between two highly complementary organisations. Significant opportunities for value-creation by working together on an ‘arms-length’ basis. The continued personal commitment from Zentiva’s senior management....
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THE issue for most Filipinos in the legal tussle between Pfizer and the Philippine International Trading Corp. (PITC) is not intellectual property rights but the high cost of prescription drugs.
On March 1 Pfizer sued the PITC and the Bureau of Food and Drugs (BFAD) for patent infringement....
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Gurgaon, Haryana, India, March 29, 2006 - Key Highlights:
Ø Ranbaxy acquires 96.7% of Terapia from Advent International for US $324m, equating to a valuation of 11.6x LTM (last twelve months) EBITDA. On a full-year 2006 EBITDA the EV/EBITDA valuation is expected to be even lower. The transaction is funded from the proceeds of Ranbaxy’s recent FCCB issue. Completion expected within Q2 2006....
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Philadelphia, PA – March 30, 2006 – Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced the signing of a multi-part agreement with AZAD Pharma AG, a corporation based in Toffen, Switzerland, to jointly develop and commercialize one pharmaceutical product and enter into a supply agreement for five Active Pharmaceutical Ingredients (APIs)....
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Jerusalem, Israel, March 30, 2006 - Teva Pharmaceutical Industries Ltd. announced today that it has increased its equity ownership in Tianjin Hualida Biotechnology Co., Ltd. in Tianjin, from 45% to 60%....
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The Federal Trade Commission today announced its intention to conduct a study of the use, and likely short- and long-term competitive effects, of authorized generics in the prescription drug marketplace. An authorized generic is chemically identical to a particular brand-name drug, but the brand-name manufacturer authorizes it to be marketed in a generic version. This study continues the FTC’s research and development efforts to identify and report on marketplace trends and developments that affect the price of prescription drugs....
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Aurobindo is pleased to announce that the company has been given the license to market Stavudine & Didanosine, two important Antiretrovirals by Bristol-Myers Squibb Company. One of the objectives of this license is to increase access of the products for the benefit of the people in the aforesaid territory specifically for the treatment of HIV/AIDS. The license covers 49 countries including South Africa....
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The Federal Court of Australia has confirmed a lengthy injunction preventing Mayne Pharma from marketing a generic version of epirubicin but Mayne intends to appeal....
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Gurgaon, Haryana, India, March 30, 2006 - Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, and amongst the top ten global generic pharmaceutical players, announced that it has acquired a generics company, Ethimed NV, in Belgium....
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The Parliamentary Secretary to the Minister for Industry, Tourism and Resources, Mr Bob Baldwin, introduced the Intellectual Property Laws Amendment Bill 2006 into the House of Representatives today. Dr Ian Heath, the Director-General of IP Australia, the Government agency responsible for the administration of the patents, trade marks, designs and plant breeder’s rights systems in Australia, said that the Bill amends several pieces of intellectual property legislation, to introduce new policy initiatives and improve the operation of the legislation....
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FORT LEE, N.J., March 31 /PRNewswire-FirstCall/ -- Alpharma Inc. announced today that it completed its previously announced sale of ParMed Pharmaceuticals, Inc. (ParMed), its generic pharmaceutical telemarketing distribution business, to Cardinal Health, Inc. , for $40.1 million in cash....
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The Food and Drug Administration (FDA), an agency of the U.S. Department of Health and Human Services today issued the first generic approval for the capsule dosage form of zidovudine to treat HIV/AIDS to be marketed in the United States. The tablet and oral solution dosage forms of zidovudine were previously approved for sale in the United States when the patent on those dosage forms expired in September 2005....
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Wilmington, MA. March 31, 2006 - DUSA Pharmaceuticals, Inc. reports that a lawsuit was filed by River’s Edge Pharmaceuticals, LLC on March 28, 2006, alleging, among other things, that Sirius Laboratories, Inc., a wholly-owned subsidiary of DUSA, agreed to authorize River's Edge to market a generic version of Nicomide®, and that the United States patent covering Nicomide® issued to Sirius in December, 2005 is invalid....
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ROCKVILLE, Md., March 31, 2006--The Food and Drug Administration (FDA) announced the tentative approval of a co-package of three antiretroviral drugs used together to initiate treatment against HIV/AIDS. The regimen, consisting of lamivudine/zidovudine fixed dose combination tablets and efavirenz tablets, is for the treatment of HIV-1 infection in adults. It is manufactured by Aurobindo Pharma Ltd. of Hyderabad, India....
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