Generics Industry News Search
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April 2008 News Archive |
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In light of recent news reports in which the generic drug industry's lobby group has mischaracterized the Biotechnology Industry Organization's (BIO) position on follow-on biologics, BIO issued the following statement to set the record straight:...
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Breckenridge announced today that it has entered into another separate agreement with Helm AG to develop and manufacture a generic ANDA product....
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Nabi Biopharmaceuticals (Nasdaq:NABI) announced today a settlement of the patent infringement case against Roxane Laboratories that involved Nabi's former product, PhosLo(r) (calcium acetate) GelCaps. The settlement between Fresenius Medical Care Holdings, Inc., Roxane Laboratories, Inc. and Nabi was made to the mutual satisfaction of all parties and was reviewed and accepted by the U.S. District Court of the Southern District of Ohio. ...
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Taro Pharmaceutical Industries Ltd. reported today that it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg...
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Earlier this year, The FDA Law Blog reported on the U.S. District Court for the District of Columbia's January 24, 2008 order dismissing Nu-Pharm Inc.'s complaint against FDA seeking declaratory and emergency injunctive relief with respect to Nu-Pharm's ANDA #77-615 for a generic version of Abbott Laboratories' Depakote (divalproex sodium) Delayed-Release Tablets, 500 mg....
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India's largest drug maker Ranbaxy Laboratories Ltd on Thursday announced the launch of 'Bonisa - teriparatide' injection used in the treatment of osteoporosis disease in collaboration with Hyderabad-based Virchow Biotech Pvt Ltd....
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Hyderabad, India: Dr. Reddy's Laboratories Ltd (NYSE:RDY) announced today that it has acquired Jet Generici Srl, a company engaged in the sale of generic finished dosages in Italy....
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In the contentious debate over insuring Americans' health, the value of generic prescription drugs is a rare point of consensus. Patients, physicians, employers, politicians - all hail generics as powerful treatment for a swelling health-care tab....
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The waiver provisions in the FDA's draft guidance of bioequivalence requirements for generic versions of Medicis Pharmaceutical's once-daily oral acne drug would put the public at risk, the company argues in a citizen petition....
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The Federal Circuit determined that the District Court for the District of New Jersey properly construed claim 1 of U.S. Patent No. 4,513,006 to encompass Plaintiff-Appellee Ortho-McNeil Pharmaceutical, Inc.'s epilepsy drug topiramate, and affirmed the District Court's decision...
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Depomed, Inc. (NASDAQ:DEPO) announced today that it has reached a settlement with IVAX Corporation and its parent company, Teva Pharmaceuticals, of all claims associated with the patent infringement lawsuit filed by Depomed against IVAX in January 2006, in which Depomed alleged infringement of Depomed's patents (U.S. Patent Nos. 6,340,475 and 6,635,280) by IVAX's extended release metformin hydrochloride tablets.
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Mumbai: After dragging leading multinational drug makers Pfizer Inc. and F Hoffman-La Roche Ltd into a licensing spat over their cancer drugs Sutent and Tarceva, Hyderabad-based Natco Pharma Ltd, a cancer drugs specialist, is planning another patent fight against Pfizer's new anti-HIV/AIDS drug Celzentry....
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Ranbaxy Laboratories Limited (Ranbaxy) today announced that the Company has received authorization from Ministry of Health and Labour Welfare (MHLW-Japan) for marketing the generic version of Amlodipine tablets 2.5mg & 5mg.
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Ranbaxy Laboratories Limited (Ranbaxy) has entered into a collaborative research agreement with the Department of Biotechnology (DBT), New Delhi, in the area of New Drug Discovery Research (NDDR). The research will be conducted under the aegis of DBT's major initiative in the area of tuberculosis....
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Salix Pharmaceuticals, Ltd. today announced that the Company and its licensor, Norgine B.V., have received a purported notice of Paragraph IV Certification on behalf of Novel Laboratories, Inc. advising of the submission of an Abbreviated New Drug Application (ANDA) for MOVIPREP (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution). Novel is a privately-held company that has been affiliated with Elite Pharmaceuticals, Inc. ...
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Dabur Pharma Ltd., India's leading oncology player, today announced that it has recently signed an agreement with the Government Pharmaceutical Organization (GPO) of Thailand for generic version of one of its key anticancer products....
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Hi-Tech Pharmacal Co., Inc. announced today that the US Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for dorzolamide hydrochloride with timolol maleate ophthalmic solution....
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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Columbia has granted a request of the Company's subsidiary, Teva Pharmaceuticals USA, Inc. that the U.S. Food and Drug Administration (FDA) relist in the Orange Book U.S. Patent No. 5,158,952 and grant Teva 180-day exclusivity for a generic version of Janssen Pharmaceutical's Risperdal (Risperidone) Tablets....
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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that on April 8, 2008, the Court of First Instance in Brussels, Belgium, decided to revoke the Belgium part of Merck Sharp & Dohme's ("MSD") European Patent No. 1,175,904, due to lack of inventive step....
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For almost three years now, a mystery company has foiled Nastech Pharmaceutical's hopes of bringing its first product to market....
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St. Louis, MO - KV Pharmaceutical Company (NYSE: KVa/KVb), a fully integrated specialty pharmaceutical company that develops, manufactures, acquires and markets technology differentiated branded and generic/non-branded prescription pharmaceutical products, announced today that it has initiated launch shipments of Evamist (estradiol transdermal spray) to wholesalers....
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Merck & Co. Inc. lost a second round in its battle with the generic drug maker Perrigo Co. on Monday, as a patent appeals court upheld its loss in a lower court....
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Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that it has reached several agreements with AstraZeneca. Two of these agreements concern Esomeprazole magnesium capsules....
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Insmed Inc., a Richmond, Virginia-based developer of follow-on biologics and biopharmaceuticals, announced receipt of a letter and questionnaire from the Chairman and Ranking Member of the U.S. House of Representatives' Subcommittee on Health on the possible development of legislation to establish a Follow-On Biologics (FOB's) regulatory pathway....
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Eurand N.V. announced today that Chiesi Farmaceutici SpA, an Italian pharmaceutical company, has granted Eurand Pharmaceuticals Inc. (Eurand), Affiliate of Eurand N.V., an exclusive license to its gastro-resistant, controlled release tablet formulation of the corticosteroid, beclomethasone dipropionate, in the United States and Canada....
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With dozens of biotech and drug company CEOs flying to Capitol Hill to meet with members of Congress, The Coalition for a Competitive Pharmaceutical Market (CCPM) today released a new advertisment urging members to keep the best interests of patients in mind as they consider legislation to create a workable approval pathway for safe, effective and affordable biogeneric medicines....
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IMPAX Laboratories, Inc. reports that the U.S. Food and Drug Administration (FDA) has issued its report concerning the Therapeutic Equivalence of Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg and found that our generic buproprion extended-release tablets, marketed as Budeprion XL 300 milligram by our partner Teva Pharmaceutical USA, is a safe and effective choice for consumers in treating depression....
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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 (ANDA) to market its generic version of Lilly's osteoporosis treatment Evista (Raloxifene Hydrochloride) Tablets, 60 mg and its generic version of Merck's migraine pain treatment Maxalt (Rizatriptan Benzoate) Tablets, equivalent to 5 mg and 10 mg base....
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Pfizer Inc. said today that the Canadian Federal Court has upheld a Pfizer patent covering amlodipine besylate, the active ingredient in Norvasc....
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Boca Raton, Florida - Breckenridge Pharmaceutical Inc. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novo Nordisk's Activella Tablets (Estradiol/Norethindrone Acetate 1.0mg/0.5mg) Tablets....
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DETROIT - Caraco Pharmaceutical Laboratories, Ltd. has confirmed that the United States District Court of New Jersey has granted Caraco's motion for summary judgment that the claims of U.S. Patent No. 39,221 that Ortho-McNeil Pharmaceutical, Inc. asserted against Caraco are invalid....
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APP Pharmaceuticals Inc., a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Colistimethate for Injection, USP, 150 mg, the generic equivalent of JHP Pharmaceuticals' Coly-Mycin M Parenteral....
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EDISON, N.J. - Heritage Pharmaceuticals Inc. announced the immediate availability of Nimodipine Soft Gelatin Capsules in 30 mg strength....
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STOCKHOLM, Sweden - Meda, through its wholly owned U.S. subsidiary, Meda Pharmaceuticals Inc., has entered into a settlement agreement with Apotex Inc. and Apotex Corp. (hereafter Apotex) that resolves the U.S. patent litigation between the companies regarding Apotex's proposed generic versions of Astelin and Optivar....
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PITTSBURGH - Mylan 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 Felodipine Extended-release Tablets USP, 2.5 mg, 5 mg and 10 mg....
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Bayer confirmed that Bayer Schering Pharma AG and Bayer HealthCare Pharmaceuticals Inc. filed a patent infringement lawsuit in U.S. Federal Court in the Southern District of New York (New York) against Watson Pharmaceuticals, Inc., Watson Laboratories, Inc. and Sandoz, Inc....
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Hawthorne, N.Y. - Taro Pharmaceutical Industries Ltd. reported today that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for cetirizine hydrochloride oral solution, 1 mg/1 ml ("Cetirizine Oral Solution")....
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The Brazilian government recently declared the drug Tenofovir, used against HIV/AIDS, to be of public interest. The announcement signals the country's interest in using an option to avoid the patent on the drug and beginning the process of issuing a compulsory license for the antiretroviral which is produced by the Gilead Science biopharmaceutical company. ...
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The chief executive of one of the world's largest generic drug manufacturers said this evening in Ann Arbor that the health care industry should embrace generics as a tool for containing escalating health care costs....
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Ranbaxy Laboratories Ltd. and Orchid Chemicals and Pharmaceuticals Ltd. today announced that they have entered into a Business Alliance Agreement involving multiple geographies and therapies for both finished dosage formulations and active pharmaceutical ingredients....
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Last August, the U.S. Patent and Trademark Office published a notice of proposed rule making entitled 'Examination of Patent Applications That Include Claims Containing Alternative Language' (sometimes referred to as the Markush rules). The Office's proposed rule making would require each claim in an application to be limited to a single invention....
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A former senior vice president at Bristol-Myers Squibb has been indicted on federal charges of negotiating a secret pact between the company and a generic drug maker and then hiding the deal from federal regulators....
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Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today confirmed that its subsidiary Watson Laboratories, Inc. (a Nevada Corporation) has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its Fentanyl Buccal Tablets C-II product prior to the expiration of patents owned by Cephalon, Inc....
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Lannett Company, Inc. (AMEX:LCI), 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 Dipyridamole Tablets USP, 25mg, 50mg, and 75mg, the generic equivalent of Persantine(R) Tablets manufactured by Boehringer Ingelheim GmbH. ...
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The U.S. Patent and Trademark Office has issued another preliminary rejection of Pfizer Inc.'s request for the reissue of a patent for cholesterol drug Lipitor....
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Ohm Laboratories Inc (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Oral Solution (Allergy) and Children's Cetirizine Hydrochloride Oral Solution (Hives-Relief), 1 mg/ml (OTC). ...
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The European Generic Medicines Association (EGA) has hit back at efforts by the research-based industry to sow doubts about the safety, quality and comparability of biosimilar medicines as a real market for follow-on versions of biotechnology products starts to emerge in the European Union....
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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company’s Abbreviated New Drug Application (ANDA) to market its epoprostenol, the first generic version of GlaxoSmithKline’s Flolan® for Injection. ...
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GPs face fresh restrictions on their prescribing of branded drugs after the Government confirmed it is to introduce a new target to encourage Primary Care Trusts (PCTs) to raise the bar on generic prescribing....
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CORONA, California - Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration ('FDA') has completed the inspection of the company's Florida manufacturing facilities and has informed the Company that it has removed the Official Action Indicated ('OAI') status at Watson's Davie, Florida site....
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PITTSBURGH - Mylan 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 Trandolapril Tablets, 1 mg, 2 mg and 4 mg....
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WASHINGTON - A fight has erupted in Congress over the question of whether drug makers and other companies should be allowed to keep patents they obtained by misrepresentation or cheating.
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The bicameral conference committee to resolve the disagreeing provisions between the House and Senate versions pertaining to 'An Act To Provide For Quality Affordable Medicines' has concluded satisfactorily and successfully....
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Pfizer Inc. announced today that the U.S. Patent and Trademark Office has issued a communication notifying the company that it will confirm the patentability of the claims of Pfizer's '893 basic patent for Lipitor. ...
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