Generics Industry News Search
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April 2010 News Archive |
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Genepharm will be known as Ascent Pharmaceuticals from today in order to align the business more closely with its growing international brand...
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Glenmark Generics Limited has reported that its US subsidiary Glenmark Generics has received final ANDA approval for Moexipril Hydrocholoride 7.5mg and 15 mg tablets from the FDA and...
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Israel-based generic drug maker Teva Pharmaceutical Industries Ltd. said Thursday that the US District Court for the District of New Jersey has dismissed a patent infringement litigation pertaining to Teva's generic version of Sanofi-Aventis and Debiopharm's Eloxatin, or oxaliplatin injection...
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A U.S. federal court has upheld a patent for Teva Pharmaceutical Industries Ltd's Seasonique birth-control pill in a case against generic drugmaker Watson Pharmaceuticals Inc...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the Southern District of Indiana issued a decision yesterday on two patents for Gemzar (gemcitabine); the compound patent expiring on November 15, 2010, and a method of use patent expiring on May 7, 2013. As to the method of use patent, the Court denied Lilly's request for an injunction on the grounds that the Eastern District of Michigan had previously found that patent invalid. Lilly has appealed that decision and oral argument is scheduled for May 7, 2010....
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The Mukesh Ambani-owned Reliance Life Sciences plans to launch its biosimilar drug to stimulate red blood cell production in Europe within a year since it has completed all required testing and now awaits final regulatory approval....
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Generic drug maker Perrigo Co. said Monday that the company along with its partner Cobrek Pharmaceuticals Inc, have got final approval from the U.S. Food and Drug Administration to manufacture and market Clindamycin Phosphate Foam 1%, a generic version of Evoclin Foam 1% of Stiefel laboratories...
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NeoStem Inc., an international biopharmaceutical company with operations in the U.S. and China, announced that its Suzhou Erye Pharmaceutical subsidiary recently received approval from the State Food and Drug Administration (SFDA) in China to manufacture the sterile active pharmaceutical ingredient of the anti-infective cloxacillin sodium. Cloxacillin sodium, a generic form Cloxapen, in finished dosage form is listed in China's National Medical Reimbursement Insurance List and thus is eligible for reimbursement by the government's healthcare programs...
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Drug firm Fresenius Kabi Oncology, previously know as Dabur Pharma, on Monday said that it has settled the patent litigation with Sanofi Aventis over the cancer drug 'Eloxatin'....
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Merck & Co. said Monday it is suing to stop Novartis AG's Sandoz division from selling a generic version of its antifungal drug Cancidas...
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Hospira has reached an agreement with Sanofi-Aventis to settle a patent dispute for the US sales of oxaliplatin injection, a generic version of Sanofi-Aventis' Eloxatin.
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Shire plc announces that it has received a second Paragraph IV Notice Letter this time from Actavis Elizabeth LLC advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV. Shire had previously reported in March 2010 of the receipt of a Paragraph IV Letter from Teva Pharmaceuticals USA, Inc. regarding Teva's ANDA for a generic version of Shire's 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets....
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GenericsWeb, a leader in established pharmaceutical patent searching and analysis, recently published an article based on its proprietary patent intelligence for AstraZeneca's Naropin(Ropivacaine). The article analyses the patent landscape surrounding Ropivacaine, highlighting the need for comprehensive patent information in the development of launch strategies for generic products to minimise the risk of litigation...
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Glenmark Generics Limited, the European subsidiary of Glenmark Generics Limited, today announced the start of marketing of Ropinirole film-coated tablets and Lercanidipin in the UK......
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Aton Pharma Inc. has launched an authorised generic version of its timolol maleate ophthalmic gel-forming solution (Timoptic-XE)...
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Teva Pharmaceutical Industries Ltd announced today that the U.S. Food and Drug Administration has granted final approval for the Company's generic versions of Merck's antihypertensive agents Hyzaar (hydrochlorothiazide; losartan potassium) and Cozaar (losartan potassium)....
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution (with Flavor Packs), the generic version of Braintree Laboratories' NuLytely laxative....
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application to market a generic version of GlaxoSmithKline's Wellbutrin SR Extended Release tablets....
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Hyderabad based pharma company, Natco Pharma announced the commercial launch of 'Bendit' - Bendamustine, a novel agent in the treatment of Chronic Lymphocytic Leukemia or CLL, mostly seen in elderly people....
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Mylan Inc. (MYL) received approval from the US Food and Drug Administration (FDA) for the generic version of Braintree Laboratories' NuLytely, a laxative...
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Aurobindo Pharma Limited is pleased to announce that it has received the final approval for Venlafaxine Hydrochloride Tablets 25mg, 37.5mg, 50mg, 75mg and 100mg from the US Food & Drug Administration...
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Cipla has launched a generic version of the German innovator's kidney cancer drug Nexavar (sorafenib tosylate). The Mumbai-based company's drug, called Soranib, will cost Rs 27,960 for a month's treatment, as against Rs 280,000 for Bayer's Nexavar. Bayer holds a patent on Nexavar in India and Cipla had filed a post-grant opposition, which is currently pending....
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Cephalon, Inc. announced that it has today completed its previously announced acquisition of Mepha, the Swiss-based pharmaceutical company. As a result of the acquisition, Mepha is now a wholly-owned subsidiary of Cephalon...
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Penwest Pharmaceuticals Co. said it entered into an agreement with privately held generic manufacturer Alvogen Inc to select up to five compounds for generic development...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application to market a generic version of Forest Laboratories Inc's Namenda 5 mg and 10 mg tablets....
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Glenmark Generics, USA (GGI), the United States subsidiary of Glenamrk Generics (GGL), today announced the settlement of litigation pending between Glenmark and GlaxoSmithKline (GSK) over patent actions concerning...
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There is no higher priority at the Federal Trade Commission (FTC) than stopping pharmaceutical companies from entering into certain types of patent settlements, i.e., settlements with an agreed-upon date for the generic to enter plus a payment from the branded manufacturer to the company producing the generic version...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Losartan Potassium and Hydrochlorothiazide (HCTZ) Tablets...
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Endo Pharmaceuticals and Penwest Pharmaceuticals announced today that the companies have settled litigation with Barr Laboratories...
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Perrigo Company and Graceway Pharmaceuticals, LLC., today announced that they have entered into an agreement to settle all existing patent litigation regarding Perrigo's ANDA filing No. 78-837 or generic imiquimod...
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Aurobindo Pharma Limited is pleased to announce that it has received the final approval for Ondansetron Orally Disintegrating Tablets (ODT) USP 4mg and 8mg from the US Food & Drug Administration (USFDA)...
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Bangalore-based pharma company, Strides Arcolab Limited today announced that it has received approval for two Abbreviated New Drug Applications (ANDAs) filed with Para IV certification to market Granisetron chemotherapy. Granisetron hydrochloride injection will be made available in 0.1 mg per ml and 1.0 mg per ml single-dose vials and 4 mg per 4 ml multi-dose vials. According to 2009 IMS data, the US market for Granisetron hydrochloride injection approximated $26 million....
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POZEN Inc. today announced that it has entered into a Settlement Agreement with Teva Pharmaceuticals USA (Teva) to resolve a U.S. patent infringement suit related to Teva's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) to market a generic version of Treximet(R) (sumatriptan/naproxen sodium) marketed by POZEN's exclusive U.S. licensee, GlaxoSmithKline. Under the terms of the Settlement Agreement, Teva will be dismissed without prejudice from the consolidated litigation currently pending in the United States District Court for the Eastern District of Texas against Teva, Par Pharmaceutical, Alphapharm Pty Ltd and Dr. Reddy's Laboratories, but will agree to be bound by the outcome of such litigation or any resulting settlements with third parties....
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Santarus, Inc., a specialty biopharmaceutical company, today announced that the U.S. District Court for the District of Delaware has ruled that five patents covering Santarus' ZEGERID(R) (omeprazole/sodium bicarbonate) prescription products are invalid due to obviousness...
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Perrigo Company today announced that it has been named as an authorized generic partner by Ferndale Laboratories and has launched an authorized generic of Analpram HC Cream. Perrigo will also have the opportunity in the future to launch other Ferndale products as the authorized generic distributor. ...
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Akorn, Inc. a niche generic pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of Dilaudid-HP(R) 10mg/ml Injection...
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Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc. - Florida, has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for metoprolol succinate extended-release tablets USP in the 100 and 200 mg strengths, the generic equivalent to AstraZeneca's Toprol XL tablets. Watson intends to begin shipping the product next week....
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The FDA issued a warning to Canadian generic drug maker Apotex last month, citing its Toronto facility for manufacturing problems and alleging use of contaminated ingredients...
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Aurobindo Pharma Limited is pleased to announce that it has received the approvals for its Abbreviated New Drug Submission for Cefprozil Tablets 250 mg & 500 mg and Cefprozil Powder for Oral Suspension (PFOS) 125 mg/5ml & 250 mg/5 ml from Health Canada...
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H. Lundbeck A/S (Lundbeck) has been informed of a favorable ruling from the City Court in Elsinore in a preliminary injunction case in Denmark. The decision means that generic versions of escitalopram in Denmark have to be removed from the market...
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Japan-headquartered innovator drug company, Takeda Pharmaceutical Company Ltd, sued Ahmedabad-based Cadila Healthcare and its US subsidiary Zydus Pharmaceuticals (USA) Inc, alleging that the Indian drugmaker is infringing upon the former's patent...
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Par Pharmaceutical Companies, Inc. today announced that the U.S. District Court for the District of Delaware has ruled in favor of Par in its challenge of the University of Missouri's patents relating to omeprazole/sodium bicarbonate capsules and...
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Sandoz has signed a definitive agreement to acquire Oriel Therapeutics, a privately held US pharmaceuticals company, gaining exclusive rights to a portfolio of generic drug candidates and related technologies targeting medicines in the inhalable respiratory drug market...
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Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Didanosine Delayed-release Capsules...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Clozapine Tablets USP, 50 mg and 200 mg...
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Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Ondansetron Injection USP...
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Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Imipramine Pamoate Capsules
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Strides Arcolab Limited (Strides) today announced receipt of ANDA approval for its Abbreviated New Drug Application (ANDA) to market Mesna injection...
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In a Form 8-K, Medicis Pharma disclosed that it has received a Paragraph IV Patent Certification from Ranbaxy Laboratories Limited advising that Ranbaxy has filed a supplement or amendment to its earlier filed ANDA assigned ANDA number 91-118 with the U.S. FDA for generic SOLODYN in its forms of 65mg and 115mg strengths....
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Novartis has lately filed a civil lawsuit against the Mumbai-based generic manufacturer Macleods Pharmaceuticals Limited for...
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Lupin Limited announced today that its U.S subsidiary, Lupin Pharmaceuticals, Inc. has received the final approval for the company's Abbreviated New Drug Application for its Imipramine Pamoate capsules, 75 mg, 100 mg, 125 mg and 150 mg from the U.S. Food and Drug Administration. Commercial shipments of the product have already commenced....
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Glenmark Pharmaceuticals has gained the upper hand in a legal battle against Merck over a cholesterol control pill after a US court rejected most of the American drug company's patent claims...
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Akorn, Inc. a niche generic pharmaceutical company, today announced that the U.S. Food and Drug Administration has granted approval of the Company's Abbreviated New Drug Application supplement for Erythromycin Ophthalmic Ointment USP 3.5 g. The company intends to begin shipping the product immediately
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Valeant Pharmaceuticals International today announced that it has signed a binding agreement to acquire a privately-held pharmaceutical company located in Brazil, for 97 million Brazilian reals (approximately US$56 million)...
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Strides Arcolab Limited today announced receipt of approval for its Abbreviated New Drug Application to Market Metoprolol Tartrate injection, USP commonly used in the treatment of acute myocardial infarction...
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Strides Arcolab Limited (Strides) today announced that the U.S. Food and Drug administration had granted tentative approval of adenosine injection, USP, the generic equivalent of Astellas Pharmaceuticals' Adenoscan...
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Drug companies have lost a legal battle against schemes promoted by Britain's state health service that encourage doctors to prescribe cheaper medicines...
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Ecuador this month granted its first compulsory licence for a patented pharmaceutical since declaring last year that it would utilise international rules allowing it to do so...
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A generic-drug manufacturer has applied for U.S. regulatory approval to sell copycat versions of Pfizer Inc.'s Sutent cancer drug before its patent protection expires....
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Therapeutic Proteins Inc. (TPI) today announced the completion of the nation's first independent, dedicated, follow-on biologics (or biosimilars) manufacturing facility constructed to meet U.S. Food and Drug Administration (FDA) requirements...
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Shire plc, the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals...
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Sun Pharmaceutical Industries Ltd. announced that a jury returned a verdict in the patent litigation over generic Protonix(R) currently on in the U.S. District Court for the District of New Jersey...
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Dr. Reddy's Laboratories announced today that it launched amlodipine benazepril capsules (2.5mg/10mg, 5mg/10mg, 5mg/20mg, 10mg/20mg), a bioequivalent generic version of Lotrel Capsules, in the US market on April 23, 2010. In September 2009, Dr. Reddy's had entered into a patent settlement with Novartis on amlodipine benazepril stipulating the dismissal of the lawsuits in the United States. The United States Food & Drug Administration granted an approval of Dr. Reddy's ANDA for amlodipine benazepril on April 15, 2010....
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market Methamphetamine Hydrochloride Tablets USP, 5 mg, based on an agreement with licensing partner Coastal Pharmaceuticals. This product, used for the treatment of attention deficit hyperactivity disorder or obesity, is the first generic version of Lundbeck's Desoxyn to be approved by the U.S. Food and Drug Administration (FDA)....
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Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, today announced they have been granted approval by the United States Food and Drug Administration (U.S. FDA) for Norethindrone tablets 0.35mg...
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., a Nevada Corporation, has been sued by Teva Women's Health, Inc., in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for synthetic conjugated estrogens, A, in the 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg tablet strengths. Watson's ANDA is for the generic equivalent of Teva's Cenestin. The suit was filed on April 23, 2010, in the United States District Court for the District of New Jersey....
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Shire plc, the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Anchen Pharmaceuticals, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets...
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U.S. regulators have warned Teva Pharmaceutical Industries about manufacturing violations at a California plant...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tamsulosin Hydrochloride Capsules USP, 0.4 mg, the generic version of Boehringer Ingelheim's benign prostatic hyperplasia (BPH) treatment, Flomax....
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Pfizer Inc. and Wyeth Pharmaceuticals Inc. in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for sirolimus tablets in the 1 mg and 2 mg strengths. Watson's ANDA is for a generic equivalent of Wyeth's Rapamune tablets product. The suit was filed on April 28, 2010 in the United States District Court for the District of Delaware....
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AstraZeneca accused nine rivals of patent infringement over plans to market a generic version of the cholesterol-control drug Crestor....
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Takeda Pharmaceutical Company Limited ("Takeda") announced today that Takeda and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlement agreements with six out of eight defendants in patent infringement litigation brought against these parties in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS (pioglitazone HCl) and ACTOplus met (pioglitazone HCl and metformin HCl). Takeda recently concluded litigation with the sixth settling defendant....
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Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) announced the settlement of the patent litigation with Forest Laboratories, Inc. relating to Memantine Tablets, Orchid's generic version of Forest Laboratories, Inc.'s Namenda Tablets used in the treatment of Alzheimer's disease....
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Impax Laboratories, Inc. today confirms that it has initiated a challenge of a patent listed by Shionogi Pharma, Inc. in connection with its Fenoglide(R) (fenofibrate) tablets, 40 and 120 mg....
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U.S.-based Pfizer Inc. is in advanced talks to acquire control of Brazilian generic drugs manufacturer Teuto, local newspaper Valor Economico reported Thursday...
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Earlier today, in "In re Ciprofloxacin Hydrochloride Antitrust Litigation", the United States Court of Appeals for the Second Circuit issued a ruling addressing whether so-called reverse payments, payments made under a negotiated settlement by a pharmaceutical patent owner to a would-be generic entrant in exchange for not entering the market, are a violation of U.S. Antitrust Law...
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In one of the most significant developments ever in the history of US healthcare, the House of Representatives finally passed HR3590, the 'Patient Protection and Affordable Care Act' which for the first time ever brings healthcare cover to the entire US population....
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for choline fenofibrate delayed-release capsules in the 45 mg and 135 mg strengths. Watson's ANDA is for a generic equivalent of Abbott's Trilipix(R) product. The suits were filed on April 27, 2010 and April 29, 2010 in the United States District Court for the District of New Jersey and Southern District of Florida, respectively....
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