Generics Industry News Search
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July 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 a generic version of Ortho McNeil Janssen's oral contraceptive, Ortho Tri-Cyclen Lo. Shipment of this product, for which Teva's trade name is Tri-Lo Sprintec, has commenced. ...
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India's Dr. Reddy's Laboratories Ltd. has received tentative approval from the U.S. Food and Drug Administration to sell generic Valacyclovir hydrochloride tablets in two doses...
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Sun Pharmaceutical Industries Ltd. announced receipt of a tentative approval from USFDA for Sun Pharma's Abbreviated New Drug Application for generic Optivar, Azelastine ophthalmic solution, 0.05%....
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Prasco Laboratories, a privately held pharmaceutical company located in Cincinnati, Ohio, announced today it has entered into a distribution and supply agreement with Axcan Pharma US, Inc. for Authorized Generic versions of URSO 250 and URSO Forte Scored (ursodiol tablets, USP) family of products...
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GlaxoSmithKline plc (GSK) today announced that it has acquired the branded generics business of Bristol Myers Squibb (BMS) in Lebanon, Jordan, Syria, Libya and Yemen for a cash consideration of $23.2m. The business comprises a portfolio of 13 branded pharmaceuticals with annual sales in 2008 of $11.8m...
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Violations of European standards by an Indian contract manufacturer have prompted recalls of multiple generic drugs in the U.K....
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The University of Iowa is involved in a legal dispute with the makers of Humira, for allegedly intentionally violating two UI patented medical tools.
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Takeda Pharmaceutical Co. sued India's Torrent Pharmaceuticals Ltd. to prevent it from selling a copy of the Actos diabetes pill in the U.S. until 2016. ...
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Teva Pharmaceutical Industries Ltd. said Tuesday it stopped shipping a generic version of Johnson & Johnson's birth control pill Ortho Tri-Cyclen....
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Canada's Apotex Inc is asking a U.S. court to rule that it did not infringe Eisai Co's (4523.T) patents on Aricept, the world's No. 1 Alzheimer's disease treatment....
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for an Abbreviated New Drug Application (ANDA) for generic Casodex, Bicalutamide tablets....
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The State University of New York, New York University, and L'Oreal subsidiary Galderma Laboratories are suing Indian generic drugmaker Lupin for allegedly infringing four patents related to Oracea, Galderma's orally administered treatment for rosacea....
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Watson Pharmaceuticals, Inc., a leader in generic and specialty branded pharmaceuticals, today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration to market its over-the-counter Nicotine Polacrilex Gum USP, 2 mg and 4 mg strengths in the coated fruit and cinnamon flavors....
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Forest Laboratories, Inc. and its wholly-owned subsidiary, Forest Laboratories Holdings, Ltd., and H. Lundbeck A/S announced today that they have entered into a settlement agreement with Sun Pharmaceutical Industries Ltd. and Caraco Pharmaceutical Laboratories, Ltd., regarding pending patent infringement disputes regarding U.S. Patent Re. No. 34,712, U.S. Patent No. 6,916,941, and U.S. Patent No. 7,420,069, which were licensed to Forest by H. Lundbeck A/S on an exclusive basis in the United States. These patents are listed in the U.S. Food and Drug Administration's Orange Book for Forest's Lexapro brand escitalopram oxalate tablet products....
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Watson Pharmaceuticals, Inc. a leading specialty pharmaceutical company, announced today that it has resumed shipments to reintroduce its intravenous iron replacement therapy INFeD (iron dextran injection, USP)....
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Glenmark Generics Inc., USA, the US subsidiary of Glenmark Generics Limited and a leading company in the manufacture, marketing and distribution of high-quality, low-cost generic pharmaceutical products in the US, initiated the launch of Fosinopril Sodium and Hydrochlorothiazide tablets in the U.S. market. ...
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Aurobindo Pharma Limited is pleased to announce that it has received final approval for Fosinopril Sodium and Hydrochlorothiazide Tablets USP 10/12.5mg and 20/12.5mg from the US Food & Drug Administration (USFDA). ...
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Declaratory judgment of non-infringement of U.S. Patent Nos. 5,879,706 (Valaciclovir Tablets Containing Colloidal Silicon Dioxide) and 6,107,302 (Guanine Derivative) in conjunction with Apotex's filing of an ANDA to manufacture a generic version of GSK's Valtrex...
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In the debate among lawmakers over generic biotech drugs, the disagreement comes down to this: How many years should makers of the brand-name biologics be protected from generic competition? ...
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Perrigo Co. said Monday it received FDA approval to market a generic version of GlaxoSmithKline PLC's Commit anti-smoking lozenge in cherry and cinnamon flavors...
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The Senate Health, Education, Labor and Pensions Committee approved an amendment late Monday that would protect makers of biologic drugs from competition from generic drug manufacturers for 12 years...
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Actavis today announced the launch of Irinotecan, a cancer drug, in the UK, France, Netherlands, Germany, Austria and Sweden on 13 and 14 July. The patents expired on 12 and 13 July, respectively. Actavis was first to market in all 6 countries....
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for TRELSTAR 22.5 mg (triptorelin pamoate for injectable suspension), a 24-week formulation of TRELSTAR for the palliative treatment of advanced prostate cancer. The TRELSTAR NDA was prepared in cooperation with Debiopharm Group, a Swiss-based global biopharmaceutical group of companies....
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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 (ANDA) with the U.S. Food and Drug Administration seeking approval to market its trospium chloride extended-release 60 mg capsules prior to the expiration of a patent owned by Supernus Pharmaceuticals, Inc. Watson's trospium chloride extended-release capsules are the generic version of Allergan Inc.'s Sanctura XR product, which is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency....
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More than 57,000 vials of the anesthetic propofol, a generic version of Diprivan, have been recalled after testing confirmed that two lots of the medication manufactured by Teva Pharmaceuticals may be tainted...
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Basel-based drug maker Hoffman-La Roche Ltd plans to drag Cipla Ltd to the Supreme Court, challenging an April ruling of Delhi high court that dismissed Roche's appeal on a patent infringement case....
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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 Abbreviated New Drug Application (ANDA) for Liothyronine Sodium Tablets USP, 5 mcg (base), 25 mcg (base) and 50 mcg (base)....
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Tris Pharma, Inc., a drug delivery and 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 12-hour sustained release Dextromethorphan liquid suspension product prior to the expiration of a patent listed in the FDA's orange book for Reckitt Benckiser's Delsym product. Deslym, a leading OTC brand and the only FDA approved 12-hour liquid product for cough is different from most brands of cough medicine as the active ingredient is "time released" in liquid syrup...
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Teva Pharmaceutical Industries Ltd. announced today that further to its press release dated July 7, 2009, the Company and Ortho McNeil Janssen have extended their agreement to cease shipments of generic versions of Ortho Tri-Cyclen Lo, until the earlier of (a) the Court's ruling on the motion for preliminary injunction or (b) July 29....
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Pharma Israel, which represents international pharmaceutical companies in Israel, has asked for "friend of the court" standing in the petition to the Supreme Court filed by Danish company H. Lundbeck A/S against the Manufacturers Association of Israel and generic drug maker Unipharm Ltd....
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The investigation into the anti-competitive conditions in the pharmaceutical sector was begun by the European Union Commission on January 15, 2008. The Preliminary Report was released in December 2008 (Refer to previous post titled "Prelim report points to anti-competitive practices in EU's Pharma industry"). The investigation; "Pharmaceutical Sector Inquiry" launched by the Commission under Article 17 of Regulation 1/2003 (of 16 December 2002) on the implementation of the rules on Competition laid down in Articles 81 and 82 of the Treaty...
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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 Haloperidol Tablets USP, 10 mg and 20 mg. These strengths are in addition to Mylan's currently marketed 0.5 mg, 1 mg, 2 mg and 5 mg strengths of the product....
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Ranbaxy Laboratories Limited (RLL), announced today that the Company has received final approval in Canada to manufacture and market Ran-Amlodipine Tablets, 5 and 10 mg (Amlodipine Besylate Tablets) from Health Canada, Therapeutic Products Directorate (TPD). Total generic market size of Amlodipine Besylate Tablets in Canada is $456 million ($CAD) [IMS-CDH: May 2009)]. Ran-Amlodipine Tablets are indicated and employed as an antihypertensive-antianginal agent....
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Ranbaxy Pharmaceuticals Canada Inc., a wholly owned subsidiary of Ranbaxy Laboratories Limited, announced today that RLL has received approval in Canada to manufacture and market Ran-Simvastatin 5 mg, 10 mg, 20 mg, 40 mg and 80 mg tablets (Simvastatin) from Health Canada, Therapeutic Products Directorate ...
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Synthon is announcing that it has successfully completed multiple decentralized procedures (DCP) for Rivastigmine. Regulatory clearance has been obtained for Synthon's product in nearly all European countries. Registration has been obtained for multiple dosage forms including capsules (1.5, 3, 4.5 and 6 mg) and an oral solution (2 mg/ml)...
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Cobalt Pharmaceuticals Inc. is pleased to introduce the newest product in our portfolio CO Ropinirole tablet, the cost effective alternative to ReQuip.
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Ranbaxy Laboratories Limited (Ranbaxy) announced today that the Ministry of Health and Labour Welfare (MHLW-Japan), have issued a Good Manufacturing Practice (GMP) certificate for its non-sterile manufacturing site located at Dewas (India). The MHLW approval has been granted for a period of 5 years and will cover all products that are currently manufactured at this site and that will be filed in the future for Japan....
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The struggle over US biogenerics legislation is continuing. Generic drug companies are now reacting to the vote by the Senate Committee on Health, Education, Labor and Pensions, which was unfavorable to biogenerics. ...
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Teva Pharmaceutical Industries Ltd. announced today that it has entered into a definitive agreement with Ortho-McNeil-Janssen to settle the patent infringement lawsuit in the U.S. District Court for the District of New Jersey related to Teva's generic version of the oral contraceptive, Ortho Tri-Cyclen Lo...
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Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for cetirizine hydrochloride tablets (OTC), 5 mg and 10 mg. The product will be marketed by Taro's U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc. ...
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Taro Pharmaceutical Industries Ltd. said today that it has filed a lawsuit against Synerx Pharma, LLC, DPT Laboratories, Ltd. and Karalex Pharma, LLC (a subsidiary of Eagle Pharmaceuticals, Inc.) in the United States District Court for New Jersey for infringement of its United States Patent No. 7,560,445 covering its Ovide(r) (malathion) Lotion, 0.5%. ...
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The IPKat reports a very recent decision from the UK courts involving an attempted seizure of "in transit" goods. The brief facts are as below:...
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The Federal Court, in a decision released on July 17, 2009, has upheld Canada's Food and Drug Regulations as they relate to the protection of data that is submitted by innovators for the purpose of obtaining regulatory approval ...
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Mylan Inc. today reported that in addition to the press release it issued on Sunday, the company proactively and as a courtesy had contacted the U.S. Food and Drug Administration (FDA) over the weekend to bring to its attention a recent news article. As a result, the FDA visited the company's Morgantown, W.VA., manufacturing facility Monday morning and has determined that the baseless accusations in the article were unfounded. The FDA noted there was no evidence of any data deletion. All data was reviewed and was present and accounted for; the Agency agreed that this was a minor Standard Operating Procedures (SOP) deviation that existed, was fully investigated, and all corrective actions were fully implemented by Mylan....
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Watson Pharmaceuticals, Inc. a leader in generic and specialty branded pharmaceuticals, today announced a license agreement with GeneraMedix, Inc., for the exclusive US marketing rights to a generic version of Ferrlecit (sodium ferric gluconate complex in sucrose injection), a drug indicated for the treatment of iron deficiency anemia in hemodialysis patients receiving supplemental epoetin therapy....
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Generic-drug manufacturer Apotex Inc. has asked the U.S. Supreme Court to overturn a lower court ruling that upheld the patent for Plavix, the blockbuster anti-clotting drug co-marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis....
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A U.S. judge essentially restarted litigation in which the Federal Trade Commission is trying to clear the way for generic competition for drug maker Cephalon Inc.'s top-selling product...
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Ranbaxy Pharmaceuticals Canada Inc., a wholly owned subsidiary of Ranbaxy Laboratories Limited, announced today that RLL has received approval in Canada to manufacture and market Ran-Ropinirole 0.25 mg, 1.0 mg, 2.0 mg, and 5.0 mg tablets (Ropinirole Hydrochloride) from Health Canada, Therapeutic Products Directorate...
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Robert Wessman and Alvogen Group combine to build a leading international generics company. Robert Wessman, former CEO of Actavis, one of the world's leading generic pharmaceutical companies, has become Executive Chairman and a major shareholder in the company...
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If the U.S. wants to lower its annual bill for pharmaceuticals, there's a plausible way to do it: Permit drugmakers to crank out generic biotech products. Right now, the U.S. Food & Drug Administration has no mechanism for reviewing or approving these complex medicines...
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In recent weeks, the pharmaceutical industry has been in the crosshairs of antitrust enforcers in the U.S. and in Europe. Specifically, patent litigation settlements in which a brand pharmaceutical manufacturer makes a payment to a potential generic entrant in return for a delay of entry (so-called reverse payment settlements) are under attack on both sides of the Atlantic.
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Dr. Reddy's Laboratories Ltd. has launched Execar (Halometasone Cream 0.05%) in India. Used in the treatment of acute/chronic eczema & vitiligo, Execar is a potent steroid and is recommended as an alternative to Betamethasone Dipropionate and Mometasone furoate.
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Biotech drugs would be protected from competition from cheaper rivals for 12 years under a proposal adopted by a key House committee on Friday....
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Glenmark Generics Limited has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Alclometasone Dipropionate Ointment, 0.05% and will commence marketing and distribution of this product in the market immediately. In June'09, Glenmark received FDA approval for Alclometasone Dipropionate cream....
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