Generics Industry News Search
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June 2009 News Archive |
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Mylan Inc. today announced that its wholly-owned subsidiary, MP Laboratories (Mauritius) Ltd, has completed its delisting offer for the publicly held shares of Maxtrix Laboratories Limited, the world's third largest active pharmaceutical ingredient manufacturer in which Mylan acquired a controlling interest in 2007...
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Sigma Pharmaceuticals has confirmed a report in today's BusinessDay that it has launched court action against Wyeth Pharmaceuticals to release its generic version of the international pharma's successfull anti-depressent Efexor...
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Sigma Pharmaceuticals (Australia) Pty Ltd. a wholly owned subsidiary of Sigma has issued proceedings against Wyeth in the Federal Court seeking revocation of Wyeth's extended release patent in relation to Efexor XR...
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Glenmark Generics Inc. USA, a subsidiary of Glenmark Generics Limited, has received the final ANDA approval from the United States Food and Drug Administration for Hydralazine Hydrochloride Tablets. The product has been approved in the active strengths of 10mg, 25mg, 50mg and 100mg as the AB rated generis Pliva's equivalent Hydralazine Hydrochloride ...
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Stiefel Laboratories Inc., a Florida-based dermatology company, sued KV Pharmaceutical Co. last week, alleging an infringement of a patent for Duac topical gel, an acne medication...
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Par Pharmaceutical Companies, In.c Today announced that it began shipping 0.25 mg, 3 mg and 4 mg strengths of Risperidone ODT to the trade...
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European regulators gave a boost to generics makers seeking to sell their copycat versions of the Plavix bloodthinner. At its May meeting, the Committee for Human Medicinal Products recommended that six Plavix generics (a.k.a. clopidogrel) be given the EMEA thumbs-up. Four of them are made by the Swiss company Acino, and the other two are manufactured by Teva Pharmaceutical Industries and Pharmathen, respectively....
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Par Pharmaceutical Companies, Inc. today announced that it began shipping 0.25 mg, 3 mg and 4 mg strengths of risperidone ODT to the trade. Risperidone ODT is a generic version of Janssen Pharma\'s Risperdal M-TAB. Annual U.S. sales of Risperdal M-TAB were approximately $89 million in 2008, according to IMS Health data. Par has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for these three strengths of the product....
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Mylan Inc. Chief Operating Officer Heather Bresch today testified before the U.S. House of Representatives Judiciary Subcommittee on Courts and Competition Policy concerning patent litigation settlements between branded pharmaceutical companies and generic pharmaceutical companies. During her testimony, Bresch conveyed Mylan position that the launch of an authorized generic by brand companies during a generic company 180-day exclusivity period undermines competition and delays timely access to high quality, affordable generic medications for patients, taxpayers, the government and businesses. ...
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AstraZeneca top-selling stomach ulcer and acid reflux drug Nexium faces early generic competition in Denmark, where Novartis unit Sandoz launched a cheap copycat version this week....
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Aurobindo Pharma Limited is pleased to announce that its US Joint Venture Cephazone Pharma LLC has received approval for its original Abbreviated New Animal Drug Application (ANADA) for Ceftiofur Sodium Sterile Powder from the US Food and Drug Administration Center for Veterinary Medicines.
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Even after India raised concerns with EU, troubles of generic companies which export drugs to developing countries through Europe are far from over as seizures by Dutch customs still continue. ...
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Merck & Co. and Schering-Plough Corp. were sued by a Pennsylvania fund for active and retired state employees over claims they misled consumers into paying too much for prescriptions of Zetia and Vytorin cholesterol pills. ...
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MDRNA, Inc. announced today that it has obtained full U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis and that Par Pharmaceutical Companies, Inc. has launched the product. ...
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Par Pharmaceutical Companies, Inc. today announced that it began shipping calcitonin-salmon nasal spray to the trade. Calcitonin-salmon nasal spray is a generic version of Novartis' Miacalcin. Annual U.S. sales of Miacalcin were approximately $112 million in 2008, according to IMS Health data. ...
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KV Pharmaceutical Company of St. Louis, MO., today announced it has entered into a settlement agreement with Purdue Pharma L.P. of Stamford, Conn., in regard to the patent infringement lawsuit between the two companies...
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Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, and Synerx Pharma, LLC, announced today the FDA approval and launch of Melphalan Hydrochloride for Injection, the generic equivalent of Alkeran from GlaxoSmithKline...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market its guaifenesin pseudoephedrine HCI extended-release 600mg/60mg and 1200mg/120mg tablets prior to the expiration of patents owned by Reckitt Benckiser Inc. Watson Laboratories, Inc. - Florida's guaifenesin pseudoephedrine HCI extended-release tablet products are the generic versions of Reckitt Benckiser Inc.'s Mucinex D product, 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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Unimed Pharmaceuticals, LLC, a wholly-owned subsidiary of Solvay Pharmaceuticals, Inc, has been informed by Perrigo Israel Pharmaceuticals, Ltd. that it has fiiled an Abbreviated New Drug Application with a Paragraph IV certification to the U.S. Food and Drug Administration, seeking the approval of a generic version of Andogel (testosterone gel) 1% CIII in the United States...
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Medicis Pharmaceutical Corp. filed suit against Ranbaxy Inc. and Ranbaxy Laboratories Ltd. for allegedly trying to market a generic version of Medicis' Solodyn, according to an 8-K filing with the U.S. Securities and Exchange Commission....
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Dr. Reddy's Laboratories today announced that the U.S. Food and Drug Administration has granted approval of the Company's Abbreviated New Drug Application (ANDA) for Omeprazole Mg OTC. Shipment of the product will be phased over the remainder of the fiscal year 2010 with the first shipment likely to commence in early Q2 of fiscal year 2010...
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Amneal Pharmaceuticlas is pleased to announce the availability of its Alprazolam Extended Release Tablets in strengths of 0.5 mg, 1 mg, 2 mg and 3 mg. The company also announces the availability of its Benazepril HCl Tablets in strengths of 5 mg, 10 mg, 20 mg and 40 mg....
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Dr. Reddy's Laboratories today announced a partnership with GlaxoSmithKline plc to develop and market select products across emerging markets outside India....
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Novartis AG's Sandoz unit was sued by Johnson&Johnson, the world's largest maker of health-care products, to stop it from selling a copy of the Ortho Tri-Cyclen LO birth-control pill...
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Patent lawsuits are all in a day's work for Big Pharma, yes? Hardly a day goes by that some drugmarker doen't sue a gnerics firm in an attempt to keep copycat meds off the market. Especially now, when the much-feared patent cliff of 2011 rapidly approaches
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Watson Pharmaceuticals, Inc. today announced that it has entered into a definitive agreement to acquire privately held Arrow Group for $1.75 billion in cash and stock. The combination of Watson and Arrow will result in a global pharmaceutical company with over $3 billion in revenue, commercial operations in over 20 countries, and a robust product portfolio and pipeline. Watson expects the transaction to close in the second half of 2009, and be accretive to cash earnings per share in 2010 before synergies. ...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Temazepam Capsules USP, 22.5 mg. This strength is in addition to Mylan's currently marketed 15 mg and 30 mg strengths of the product.
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of New Jersey has granted summary judgment in Teva's favor on the issue of non-infringement with regard to Debiopharm's U.S. Patent No. 5,338,874. The patent is listed in the Orange Book for Sanofi-Aventis' chemotherapy medication Eloxatin, which had annual sales of approximately $1.3 billion in the United States for the twelve months that ended December 31, 2008, based on IMS sales data. Teva intends to inform the FDA of the court's decision and expects that its 505(b)(2) New Drug Application will receive final approval shortly.
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Actavis has launched Sildenafil tablets in Bulgaria. This is Actavis Group's first launch of the product, which also was the first generic sildenafil to enter the Bulgarian market.
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Hospira, Inc. the world leader in generic injectable pharmaceuticals, today announced that the U.S. District Court for the District of New Jersey has granted summary judgment of non-infringement in Hospira's favor with regard to Sanofi Aventis' chemotherapy medication Eloxatin, and that Hospira has tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of the product. Hospira expects full FDA approval shortly. ...
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A legal battle between US pharma giant Pfizer and Indian company Sun Pharmaceutical has escalated, with the world's largest maker of medicines alleging in court filings that in addition to the original patent that it claims Sun violated, it infringed another patent when it sought approval for its generic version of Lyrica, a blockbuster drug used to treat seizures.
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The U.S. Supreme Court rejected a lawsuit challenging Bayer AG's deal with Barr Pharmaceuticals Inc. to delay producing a generic version of Cipro, an antibiotic drug....
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On June 22nd, Senator Bill Nelson introduced S. 1315, the "Drug Price Competition Act of 2009." The bill would amend the definition of "first applicant" at FDC Act 505(j)(5)(B)(iv)(II)(bb) with respect to 180-day exclusivity eligibility so that certain subsequent ANDA applicants could trigger and also be eligible for such exclusivity...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for levonorgestrel tablets, 0.75 mg, for women seventeen years and younger. ...
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Actavis launched Finasteride in France on day one, when the originator's patent expired on Monday 22 June. The distribution of the product has already commenced....
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Perrigo Company today announced that its partner Synthon Pharmaceuticals, Inc. has filed an Abbreviated New Drug Application (ANDA) for Levocetirizine solution 2.5mg/5ml, a generic version of Xyzal(R) solution 2.5mg/5ml. Under terms of an exclusive agreement between the companies, Perrigo has sales and marketing rights in Synthon's Levocetirizine products. The Company believes that Synthon is the first to file an ANDA with a Paragraph IV certification against Xyzal(R) solution that can entitle it to 180 days of generic exclusivity upon approval....
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Japanese regulators approved a human growth hormone from Novartis AG, the first green light in Japan for a biosimilar or generic version of a biotech drug, the Swiss drugmaker said on Thursday....
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Caraco Pharmaceutical Laboratories, Ltd. announced that U.S. Marshals, at the request of the Food and Drug Administration, today arrived and seized drug products manufactured in its Michigan facilities. The seizure also included ingredients held at these same facilities. The FDA's most recent inspection of Caraco's Detroit facility, completed in May 2009, found unresolved violations of cGMP requirements as previously disclosed in our last SEC filing on Form 10-K filed June 15, 2009...
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Prasco Laboratories, a Mason-based independent authorized generic company, applauds the Federal Trade Commission (FTC) for issuing their interim report on the short and long-term effects of authorized generics on competition in the prescription drug marketplace...
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Calling it a "generous compromise" between plans laid out by powerful Democrats Rep. Henry Waxman and Rep. Anna Eshoo, the Obama administration said biogeneric drugs should be protected from competition for seven years.
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Mylan Inc. today announced that it has executed a definitive agreement with Biocon Limited, a publicly traded company on the Indian stock exchanges, for an exclusive collaboration on the development, manufacturing, supply and commercialization of multiple, high value generic biologic compounds for the global marketplace...
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Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced it has received U.S. Food and Drug Administration approval for a 500 mg vial of azithromycin for injection in the ADD-Vantage System. The anti-infective medication is a generic version of Pfizer's Zithromax for injection. U.S. sales of generic and name-brand azithromycin for injection were approximately $40 million in 2008...
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