Generics Industry News Search
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April 2009 News Archive |
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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 Abbreviated New Drug Application (ANDA) to market its generic version for Bayer Healthcare Pharmaceuticals' oral contraceptive Yaz (Drospirenone and Ethinyl Estradiol) Tablets...
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Lannett Company, Inc. today said that it will continue to manufacture and market its Morphine Sulphate products, while it works with the U.S. Food and Drug Administration (FDA) to address the agency's initiative on halting the marketing of certain narcotic drugs...
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Last Thursday, Senator Charles Schumer introduced the Promoting Innovation and Access to Life-Saving Medicine Act, the first follow-on biologics bill to be introduced in the Senate and third follow-on biologics bill to be introduced in the 111th Congress. The new bill is the Senate companion to the bill introduced in the House on March 11 by Representative Henry Waxman ...
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Shire plc announces that it has filed a lawsuit in the U.S. District Court for the Southern District of New York against Natco Pharma Limited for infringement of two of Shire's patents: U.S. Patent No. 5,968,976; and U.S. Patent No. 7,381,428...
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Teva Pharmaceutical Industries Ltd. announced today that it has commenced commercial shipment of its generic version of Shire Pharmaceuticals' Adderall XR (mixed salts of a single-entity amphetamine product) Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg...
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, said today that it is prepared to supply the U.S. market with an uninterrupted and safe supply of Digoxin Tablets, following the voluntary recall, announced yesterday, of the drug by another generic drug manufacturer...
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The Senate Judiciary Committee voted on Thursday to approve a patent reform bill that has had drug, high-tech and other industries at loggerheads for several years...
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Sanofi-aventis announced today that its subsidiary sanofi-aventis Mexico has acquired Laboratorios Kendrick in a move to accelerate sales growth and further extend its pharmaceutical portfolio in emerging markets...
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AstraZeneca Plc filed a patent infringement lawsuit against Apotex in an effort to stop the Canadian company from selling a generic version of Astra's lucrative Pulmicort Respules asthma medicine...
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Taro Pharmaceutial Industries Ltd. today reported that it received final approval from the U.S Food and Drug Administration for tis Abbreviated New Drug Application for Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg
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The US Food and Drug Administration (FDA) has granted approval for Teva to market a generic version of Bayer Healthcare Pharmaceuticals' oral contraceptive....
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Generic drugmaker Impax Laboratories Inc. confirmed it has been sued by Genzyme Corp. over its generic copy of a drug for dialysis patients.
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Gilead Sciences Inc. said it is reviewing a notice letter and has 45 days to file a patent infringement lawsuit against Teva Pharmaceutical Industries Ltd. following Teva's submission to manufacture and market a generic version of HIV drug Atripla....
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that RAPAFLO(TM) (silodosin), the company's new, uniquely selective alpha blocker for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), is available for patients by prescription. Watson received U.S. Food and Drug Administration (FDA) approval for RAPAFLO(TM) in October 2008....
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A class action complaint filed last week in New Jersey federal court claims damages for violations of the Sherman Antitrust Act by brand-name and generic manufacturers of the drug, Androgel. The case, filed by Stephen L. LaFrance Pharmacy, Inc. d/b/a SAJ Distributors and Stephen L. LaFrance Holdings, Inc., names as Defendants Unimed Pharmaceuticals Inc., Solvay Pharmaceuticals Inc., Watson Pharmaceuticals Inc., Par Pharmaceuticals, Inc. and Paddock Laboratories, Inc.
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IPCA Laboratories has received a final approval for marketing Hydrochlorothiazide Capsule in the strength of 12.5 mg from the United States Food and Drug Administration (USFDA). ...
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Hospira, a specialty pharmaceutical and medication delivery company, has received marketing authorization for piperacillin/tazobactam for injection, and has launched the product in the UK....
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Mylan Inc. today announced the settlement of all patent litigation relating to Desloratadine Tablets, 5 mg, the generic version of Schering-Plough's Clarinex allergy medication. This litigation has been pending in the U.S. District Court of New Jersey since September 2006...
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Daiichi Sankyo Company, Limited announced that it has brought patent infringement litigations against 11 generics companies for the substance patent (2008845) and usage patent (1659502) for Levofloxacin Hydrate Levofloxacin Hydrate (broad-spectrum oral anti-bacterial agents) originated by Daiichi Sankyo, has been marketed by the company in Japan since 1993...
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Actavis has launched Fluvastatin SR in the UK and the Netherlands. Actavis was first to market in both countries...
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Bedford Laboratories, a division of Ben Venue Laboratories, Inc., announced the addition of Fluconazole Injection 2 mg/mL in PVC flexible containers to its existing Fluconazole Injection line. This product is AP rated and is equivalent to Diflucan by Pfizer. Fluconazole Injection is an antifungal agent indicated for oropharyngeal and esophageal candidiasis, cryptococcal meningitis, and is also indicated for the prophylaxis of candidiasis...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market generic Roxicodone, oxycodone hydrochloride tablets...
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Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Hoffmann-La Roche Inc. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Capecitabine Tablets, 150 mg and 500 mg, the generic version of Xeloda Tablets, a chemotherapy treatment for breast and colorectal cancer...
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In yet another setback to Swiss drug multinational Novartis AG, the Indian patent office has rejected its application to secure a patent for an alfa crystal form of its blockbuster cancer medicine, Glivec.
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The Food and Drug Administration has approved Silarx's generic version of UCB's Keppra, agency records show....
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Sepracor Inc. on Friday took a step toward a potential challenge of patents supporting Pristiq, an antidepressant marketed by Wyeth....
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Actavis today announced the reintroduction by its subsidiary in the United States of Oxycodone 15 mg and 30 mg tablet products to pharmacies and customers. Oxycodone is the first product to be manufactured at Actavis' Little Falls, NJ facility following a recently completed FDA inspection...
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Chalk up another anti-generic victory for AstraZeneca. A U.S. court gave the drugmaker a restraining order that bars Apotex from selling a copycat version of AstraZeneca's top-selling asthma medicine Pulmicort Respules. Toward month's end, the court plans to determine whether the injunction should be made permanent....
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Teva Pharmaceuticals is pleased to announce the introduction and availability of Topiramate Capsules (Sprinkle). ...
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Mylan Inc. today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has been selected by the Clinton HIV/AIDS Initiative (CHAI) under its UNITAID-funded projects as the primary supplier of five antiretroviral (ARV) drugs used in second-line HIV/AIDS treatment regimens. Matrix also has been selected as the primary supplier of seven ARVs used for pediatric treatment. ...
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India has called an "extraordinary" meeting of the ambassadors of all African countries in the Capital this week to register its strong protest against a recently passed Anti-Counterfeit Act in Kenya that could severely restrict the market for Indian generic drugs into Africa....
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Par Pharmaceutical Companies, Inc. (Par) today announced it has entered into a settlement agreement with Reliant Pharmaceuticals, Inc. (Reliant) that resolves patent litigation related to Reliant's Rythmol SR product, thereby eliminating the inherent uncertainty and costs of litigation...
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Aurobindo Pharma Limited is pleased to announce that has received its first approval from Swissmedic, Government of Switzerland for the license of Finasteride APL Tablets 5mg.
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that it has filed two Abbreviated New Drug Applications with the U.S. Food and Drug Administration seeking approval to market its guaifenesin extended-release 600mg and 1200mg tablets and its dextromethorphan HBr/guaifenesin extended-release 30mg/600mg and 60mg/1200mg tablets prior to the expiration of patents owned by Reckitt Benckiser Inc. Watson's guaifenesin and dextromethorphan HBr/guaifenesin extended-release tablet products are the generic versions of Reckitt Benckiser Inc.'s Mucinex(R) and Mucinex(R) DM products which are indicated to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive....
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Dr. Reddy's Laboratories Ltd. has launched Redispar(Doxercalciferol) in India. Used in the treatment of secondary hyperparathyroidism (SHPT) due to chronic kidney disease, Redispar is the first pro-vitamin D2 to be available in the country....
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Cobalt Pharmaceuticals Inc. is pleased to introduce the newest product in our portfolio. CO Pramipexole tablet, the cost effective alternative to Mirapex.
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A U.S. District Court has granted drug maker Eli Lilly & Co. a preliminary injunction preventing the launch of a generic version of one of its drugs, Lilly announced Wednesday....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the Southern District of Indiana has granted Eli Lilly's motion for a preliminary injunction related to Teva's abbreviated new drug application to market its generic version of Evista tablets. Teva plans to appeal the decision....
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The Canadian Generic Pharmaceutical Association (CGPA) today welcomed the first ever approval of a subsequent entry biologic (SEB) in Canada and urged Health Canada to move forward with the completion of its SEB guidance without further delay....
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Recent research in the worldwide heart and lung transplant community reveal significant findings regarding challenges in the development and use of generic immunosuppression drugs for patients around the world. Tomorrow (Friday, April 24), the International Society for Heart & Lung Transplantation will feature a captivating discussion regarding the use of generic medications and the variance in quality of these drugs from nation to nation...
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Teva Pharmaceutical Industries has withdrawn its application to market a generic version of Sanofi-Aventis SA and Bristol-Myers Squibb Co's blood thinner Plavix in Europe, regulators said on Thursday...
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Pronova BioPharma ASA today announces that Pronova BioPharma Norge AS has filed a lawsuit against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. in the United States District Court for the District of Delaware asserting infringement of Pronova BioPharma's U.S. Patents Nos. 5,502,077 and 5,656,667 relating to omega-3-acid ethyl ester compositions and methods of using omega-3-acid ethyl esters. ...
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The Delhi High Court today allowed domestic drug major Cipla to sell its generic version of lung cancer drug, Erlotinib, vacating an earlier interim order restraining it from selling the drug. The earlier order was based on an appeal by Swiss multinational Hoffman La Roche...
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Glenmark Generics Ltd's US subsidiary (GGI) announced that the US Food and Drug Administration (US-FDA) has granted tentative approval for the generic version of Schering Plough and MSP Singapore Company LLC's hypercholesterolemia treatment Zetia (Ezetimibe). ...
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Indian drug maker Cipla Ltd. said Monday it can supply 1.5 million doses of a Tamiflu copycat in four-six weeks' time in response to a possible global demand for the anti-viral medication following an outbreak of swine flu....
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The U.S. Supreme Court rejected an appeal by two Sanofi-Aventis SA units, refusing to reinstate a patent that prevented generic competition to the company's top- selling product, the blood-thinner Lovenox. ...
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Dr. Reddy's Laboratories Ltd. has launched Nexret (Tretinoin 0.04% and 0.1% as microspheres) in India. It marks the entry of Dr. Reddy's into the topical anti-acne segment, a commonly diagnosed condition by dermatologist....
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its darifenacin hydrobromide extended-release 7.5 mg and 15 mg product prior to the expiration of a patent owned by Novartis AG. Watson's darifenacin hydrobromide extended-release product is the generic version of Novartis AG's Enablex(R) which is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency....
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Brimonidine Tartrate and Timolol Maleate 0.2%/0.5% Ophthalmic Solution (Combigan) Para IV filed on Nov 21, 2008. Capecitabine 150 mg and 500 mg Tablets (Xeloda). Para IV filed on Nov 10, 2008.
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Pronova BioPharma ASA (Pronova BioPharma) today announces Pronova BioPharma Norge AS has filed a lawsuit against Apotex Inc. and Apotex Corp. (Apotex) and Par Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc. (Par) in the United States District Court for the District of Delaware asserting infringement of Pronova BioPharma's U.S. Patents Nos. 5,502,077 and 5,656,667 relating to omega-3-acid ethyl ester compositions and methods of using omega-3-acid ethyl esters....
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