Generics Industry News Search
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June 2010 News Archive |
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Mumbai-based drug maker Lupin Ltd is close to making its second acquisition in Japan, where it became the seventh largest generics player after buying local firm Kyowa Pharmaceuticals Ltd in 2007 for $100 million (Rs46.5 crore today)....
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Teva Pharmaceutical Industries Ltd. announced today that it has commercially launched Gianvi (Drospirenone and Ethinyl Estradiol) Tablets, the Company's generic version of Bayer's Yaz(R) Tablets....
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Aurobindo Pharma has received the approval for its Abbreviated New Drug Submission for cefotaxime sodium for injection 0.5g, 1g and 2g from Health Canada....
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Teva Pharmaceutical Industries Ltd. today announced U.S. Food and Drug Administration (FDA) approval and commercial launch of its generic version of Galderma's product, Differin (adapalene 0.1%) Gel, which is indicated for the treatment of acne....
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The world's largest generic drug maker, Teva, on Wednesday asked a U.S. court to resolve a dispute over its unexpectedly swift introduction to the United States of a generic version of Bayer's YAZ birth control pill....
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A Baton Rouge-based pharmaceutical firm has hired two executives from Europe and will establish facilities to make protein-based drugs there over the next two years...
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With the market for biologic* drugs growing much faster than that of drugs based on chemical compounds, pharmaceutical, biotechnology, generic drug and contract manufacturing companies are repositioning and forming new alliances in order to succeed in a rapidly changing landscape...
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The largest Japanese drug firm, Takeda Pharma, has sued Hyderabad-based Dr Reddy's Labs for allegedly infringing the former's patent coverage on anti-diabetic drug Actos (Pioglitazone hydrochloride) by trying to manufacture and market the same in the US....
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Perrigo Company has obtained final US Food and Drug Administration approval for the company's Miconazole Nitrate...
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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 Anchen Pharmaceuticals, Inc. and Anchen, Inc. (collectively "Anchen") for the infringement of U.S. Patent Nos. 5,854,290 (the '290 patent), 6,287,599 (the '599 patent), and 6,811,794 (the '794 patent)....
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Emerging World Pharma Inc., strategic partner African Global Pharma (AGP), as part of an exclusive marketing and distribution agreement, will begin testing and manufacturing of generic pharmaceuticals for the Catholic Diocese of Sunyani, Ghana....
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AVESTHAGEN announced that it has successfully completed the pre-Clinical efficacy trial for one of its biosimilar drugs AVENT at Biomedcode Hellas S.A....
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Patent Docs: Biotech/Pharma Docket - June 03, 2010 By James DeGiulio - Celgene, Barr resolve patent dispute over generic Thalomid......
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Sandoz announced today that it has completed its acquisition of Oriel Therapeutics, a privately held US pharmaceuticals company, for an undisclosed sum....
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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) for its Abbreviated New Drug Application (ANDA) for Gabapentin Tablets USP......
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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 (ANDA) for its Lamotrigine tablets, 25 mg, 100 mg, 150 mg and 200 mg strengths, from the U.S. Food and Drug Administration (FDA)....
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Glenmark Pharmaceuticals Ltd has deferred the planned initial public offering of its wholly owned generics arm Glenmark Generics Ltd, because it is no longer in desperate need of money...
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Acella Pharmaceuticals has signed a licensing agreement for the U.S. marketing rights to a generic version of an intravenous administered broad-spectrum antibiotic...
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Hospira, Inc., and DURECT Corporation today announced that the companies have entered into a licensing agreement to develop and market DURECT's POSIDUR(TM) (SABER(TM)-bupivacaine), a long-acting version of the anesthetic bupivacaine currently in Phase III clinical trials....
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Ranbaxy S.A., a wholly owned subsidiary of Ranbaxy Laboratories Limited, has launched Lipogen (Atorvastatin) 10, 20, 40 and 80mg into the South African market. Ranbaxy is the first generic pharmaceutical company to launch a generic Atorvastatin in South Africa....
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Impax Laboratories, Inc. today announced that it has reached agreement with Endo Pharmaceuticals and Penwest Pharmaceuticals to settle pending U.S. litigation with regard to the production and sale of generic formulations of OPANA(R) ER (Oxymorphone hydrochloride) Extended Release tablets....
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Greece introduced new regulations for fixing the prices of drugs, which will result in prices falling by around 22% on a weighted average basis....
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APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today it received approval from the U.S. Food and Drug Administration to market Oxaliplatin for Injection (lyophilized), 50 mg and 100 mg...
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Drug maker Dr Reddy's Laboratories has received a tentative approval from the US Food & Drug Administration (USFDA) to market Zafirlukast tablets in strengths of 10 mg, 20 mg....
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Purdue Pharma has filed a patent-infringement suit against Ranbaxy, Actavis Elizabeth and Mylan Pharmaceuticals after the companies submitted applications to market a generic version of the painkiller OxyContin....
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A federal judge has thrown out generic-drug maker Wockhardt Ltd.'s claim that Sepracor Inc. misled patent examiners by covering up rat study data related to sleep drug Lunesta, saying that the allegations were weakly pled and that the disputed data wasn't relevant to the patent....
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Glenmark Pharmaceuticals has got a favourable verdict from a US court in its patent litigation against Abbott Laboratories and Sanofi-Aventis over blood pressure reduction drug "Tarka"....
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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) for Terbinafine HCl Tablets, 250mg....
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Hospira announced today that the EC has approved Nivestim(TM) (Filgrastim) for the prevention of FN, the most serious haematological toxicity that occurs as a result of cancer chemotherapy. Nivestim now has marketing authorisation in all EU member states....
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The Chennai-based generic pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) today announced that it had entered into an agreement to acquire Karalex Pharma, LLC, a US-based generic marketing and sales services company headquartered in New Jersey, USA......
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Daiichi Sankyo Company Limited and Ranbaxy Laboratories Limited announced today that Ranbaxy has launched a generic version of Prasugrel in India. The product, called Prasita, is an antiplatelet agent for...
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Jiangbo Pharmaceuticals, Inc., today announced that the Company received approval from the Chinese State Food and Drug Administration ("SFDA") to start producing Felodipine sustained release ("SR") tablets....
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Generic companies hoping to market a cheap copy of GlaxoSmithKline's best-selling inhaled lung drug Advair might have to wait until 2012 before winning a green light from regulators in Europe....
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Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Lupin Limited submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration requesting permission to manufacture and market a generic version of Ranexa(R) (ranolazine extended-release tablets)....
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GlaxoSmithKline plc today announced that it has acquired Laboratorios Phoenix, a leading Argentine pharmaceutical business, for a cash consideration of approximately $253 million...
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Cubist Pharmaceuticals, Inc. today announced that it will oppose a motion filed by the Teva defendants to amend their answer to add a new defense in the patent litigation between Cubist and Teva pending in the US District Court for the District of Delaware....
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Sandoz has opened what it calls a key site for the development of generic drugs in New Jersey, the generic drug arm of Novartis said Friday...
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Intellipharmaceutics International Inc. today announced that is has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for a generic of Protonix(R) (delayed release pantoprazole sodium)....
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Dr. Reddy's announced today that the US District Court of New Jersey has granted Sanofi-Aventis and Albany Molecular Research's motion for a Preliminary Injunction....
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Strides Arcolab announced that it has received approval from US Food and Drug Administration (USFDA) for Sumatriptan Succinate Injection 6 mg (base) / 0.5 ml, a selective agonist for a vascular 5 hydroxytryptamine receptor subtype....
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The US-based pharma company, Abbott, has sued two top Indian drugmakers, Ranbaxy Labs Ltd and Sun Pharmaceuticals in the US market alleging patent infringement in the cases of two different cholestrol drugs....
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Cipla, the largest domestic drug maker, today said it would invest $65 million (over Rs 300 crore) in three years to acquire a 40 per cent stake in an Indian biotech company and 25 per cent stake in a similar company in Hong Kong, as part of its foray into biosimilars or generics of off-patent biotech drugs....
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The Food and Drug Administration has approved a generic drug for anxiety disorder made by Amneal Pharmaceuticals, Amneal said Wednesday....
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Pfizer Inc has sued Mylan Inc, accusing the generic drugmaker of infringing patents on its cancer drug Sutent...
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AstraZeneca today announced that the Federal Court of Canada has dismissed AstraZeneca's request to prohibit the Canadian Minister of Health from issuing a Notice of Compliance (NOC) for the regulatory applications for generic esomeprazole magnesium submitted by Apotex Inc....
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Sun Pharma announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Keppra Injection, levetiracetam injection...
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Bayer Schering Pharma AG, Germany, and OncoMed Pharmaceuticals, Inc., today announced a global strategic alliance to discover, develop and commercialize novel anti-cancer stem cell therapeutics targeting the Wnt signaling pathway....
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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 for its Abbreviated New Drug Application for Hydroxyzine Hydrochloride Tablets ...
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The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet...
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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 for its Abbreviated New Drug Application for Simvastatin Tablets...
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Sun Pharma announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Xanax, Alprazolam tablets....
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APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Aztreonam for Injection, USP in two dosage strengths. Aztreonam is therapeutically equivalent to the reference-listed drug Azactam(R), which is marketed by Bristol-Myers Squibb....
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Valeant and Biovail today announced that both companies' Boards of Directors have unanimously approved a definitive merger agreement under which the companies would combine to generate enhanced value for stockholders. The combined company will be called Valeant Pharmaceuticals International, Inc. ("the new Valeant")....
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Ireland's introduction of generic substitution and reference pricing in 2011 will save the nation nearly 78 million euros a year and reduce spending by patients...
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The healthcare reform was a milestone in the history of US generic drugs industry, and this will benefit the US generic drugs industry in long-term growth scenario...
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Teva Pharmaceuticals has admitted that it made false statements on the label of Gianvi, a generic clone of Bayer's Yaz birth control pill...
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Sun Pharmaceutical Industries Ltd announced that together with its affiliates it has executed a settlement agreement with Orion stipulating a dismissal of the lawsuits filed in the United States against Sun Pharma regarding submission of Abbreviated New Drug Applications for generic versions of Stalevo(R) and Comtan(R) tablets...
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Sun Pharma announced that USFDA has granted approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Optivar, Azelastine ophthalmic solution, 0.05%....
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Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced it has received U.S. Food and Drug Administration (FDA) approval for Meropenem for injection, USP (I.V.) 500 mg and 1 g vials. The medication, a carbapenem that belongs to the beta-lactam class of antibiotics, is a generic version of AstraZeneca's Merrem(R) I.V....
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Abbott Laboratories said it settled a patent-infringement suit against Novartis AG's Sandoz over a generic version of the antibiotic Biaxin XL....
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At a time when over seventy per cent of Africans still lack access to treatments against HIV, malaria and tuberculosis, among other diseases, Cameroon has taken a giant step to develop the production of generic drugs with the help of the African Union....
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As part of the recently passed U.S. health reform package, the federal government created an approval process for similar versions of pricey biotechnology medicines designed to help patients cut their drug costs....
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Drug research companies are strengthening their task forces to protect the patents for their products, but planning far enough in advance of patent expiry remains a challenge for many teams, according to a new study....
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Watson Pharmaceuticals, Inc. announced that its subsidiary, Watson Laboratories, Inc. has received tentative approval today from the United States (U.S.) Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Fentanyl Citrate Buccal tablets, 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg....
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Dr Reddy's Laboratories may be the biggest beneficiary among Indian generic-drug makers as $157 billion of medicines including Eli Lilly & Co's Zyprexa lose patent protection within five years, HDFC Securities said....
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A collection of companies involved in manufacturing and marketing the GlaxoSmithKline clotting agent Argatroban Injection have prevailed in their efforts to keep a generic version of the drug off the market....
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Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Pfizer's Procardia XL(R) Tablets, a treatment for angina and/or hypertension...
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Bayer Inc. and Teva Canada Limited today announced they have entered an agreement regarding Bayer's Adalat(R) XL(R) (nifedipine) 20, 30 and 60 mg product....
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Sun Pharma Industries Ltd. announced that the U.S. District Court for the District of New Jersey denied Sun Pharma's motion to suspend the court's order dated April 22, 2010 which entered a Consent Judgement and Order having the effect of enjoining Sun Pharma from selling a generic oxaliplatin product...
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The Food and Drug Administrations has approved two new uses for what remains, thus far, the only biosimilar on the U.S. market....
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Cyplasin recently signed an agreement with Minapharm Pharmaceuticals to distribute and market their version of the long-acting pegylated interferon-alpha product (to be marketed and sold under Cyplasin's brand name C-Pegferon(TM)) within the North American and South American markets as well as Mexico, Latin America, Korea, Russia, China, India and other countries....
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Teva Pharmaceutical Industries Ltd. announced today U.S. Food and Drug Administration (FDA) approval and commercial launch of Anastrozole Tablets 1 mg, the Company's generic version of AstraZeneca's ARIMIDEX. The product is indicated for treatment of certain forms of breast cancer in postmenopausal women....
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Warner Chilcott plc announced today that it has received a Paragraph IV Certification Notice from Par Pharmaceutical, Inc. The Paragraph IV Certification Notice advises the Company of the filing of an Abbreviated New Drug Application (ANDA) by Par for a generic version of the Company's ASACOL 400 mg delayed release mesalamine product....
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Astellas Pharma Inc. and its US subsidiary, Astellas Pharma US, Inc. and Teva Pharmaceutical USA, Inc. announced today that the three companies have reached an agreement to settle the pending U.S. litigation with regard to US Patent No. 6,017,927 for VESIcare (solifenacin succinate) tablet through the entry of a consent judgment....
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Breckenridge Pharmaceutical, Inc. announced today that they will launch Anastrozole 1mg Tablets....
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Teva Pharmaceutical Industries Ltd. announced today U.S. Food and Drug Administration (FDA) approval of Venlafaxine HCl ER Capsules, the Company's generic version of Wyeth's antidepressant Effexor XR. Shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth....
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1 mg, the generic version of AstraZeneca's Arimidex(R) Tablets, a treatment for early breast cancer....
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AstraZeneca announced today that Judge Joseph Farnan, Jr., US District Court, District of Delaware, has found that the substance patent protecting CRESTOR (RE37314, the '314 patent) is valid and enforceable....
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Abbott Laboratories sued Mylan Inc. in federal court in Delaware, alleging infringement of eight patents and seeking to block generic copies of the cholesterol drug Simcor....
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