Generics Industry News Search
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June 2006 News Archive |
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CORONA, Calif., June 1 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application for levonorgestrel and ethinyl estradiol tablets USP, 0.1mg / 0.02mg, a generic version of Berlex's Levlite(R) product which is indicated for the prevention of pregnancy....
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Auckland-based Douglas Pharmaceuticals is selling its Australian subsidiary to generic medicines manufacturer Genepharm Australasia for $A70 million ($NZ83.6 million)....
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EXTON, Pa., Jun 01 /PRNewswire-FirstCall/ -- ViroPharma Incorporated today filed a supplement to its Petition for Stay of Action with the FDA regarding the bioequivalence requirements for abbreviated new drug applications (ANDAs) that seek to copy Vancocin. The document sets forth legal arguments in support of ViroPharma's strong belief that the decision of the FDA's Office of Generic Drugs (OGD) to lower the bioequivalence standards for generic copies of Vancocin violated numerous federal statutes and FDA's own regulations with the result that the new standard cannot, as a matter of law, be used in the review or approval of applications for generic versions of Vancocin....
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South African generic drug maker Aspen Pharmacare Holdings said on Wednesday it was in talks about making an acquisition, but gave no further details.
The firm released a statement to the stock exchange saying it was in acquisition talks, but did not say whether it was the suitor or target....
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Ranbaxy Laboratories Limited (RLL) announced today that the Company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Doxycycline Tablets 50mg, 75mg, and 100mg in the U.S. market....
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From Duncan Bucknell - www.DuncanBucknell.com
Merck Sharp & Dohme DE Espana S.A. v Bexal Farmaceutica, S.A; Provincial High Court of Madrid (00089/2006)
On 5 May 2006 the Provincial High Court of Madrid handed down ruling 89/2006 in Merck Sharp & Dohme DE Espana S.A. v Bexal Farmaceutica, S.A....
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First Indian Company to target Dermatology Portfolio in the US Generics Market
Mumbai, London & New York, June 05, 2006: Glenmark Pharmaceuticals Inc [GPI], a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. [Glenmark], the research-led global pharmaceutical company, today announced a unique royalty deal with Paul Capital Partners’ Royalty Fund [Paul Royalty], a leading, international healthcare investment fund. Under the terms of the arrangement, Paul Royalty will invest up to USD 27 million to finance the development of 16 dermatological products by Glenmark for the US market....
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IRVINE, Calif., Jun 05, 2006 (BUSINESS WIRE) -- Allergan, Inc. announced today that the United States District Court for the Northern District of California has ruled in favor of Allergan, Inc. and Syntex (USA) LLC in a patent infringement lawsuit against Apotex, Inc., Apotex Corp., and Novex Pharma (the Defendants)....
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ACCU-BREAK Pharmaceuticals, Inc. and Strides Arcolab Limited, one of India's largest manufacturers and exporters of pharmaceutical products, today announced the signing of a definitive agreement to set up a world-wide Joint Venture Company (JVC) to develop generic products using the patent pending ACCU-BREAKTM technologies. This will be accomplished through a NEWCO to be called ACCU-STRIDES, a 50:50 JVC. It is anticipated that the JVC will outsource from Strides an exclusive product pipeline of generic and ANDA products in finished dosage forms....
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Melville, New York –Specialty pharmaceutical manufacturer Fougera, a division of ALTANA Inc, today announced it is first-to-market with generic Metronidazole Topical Gel USP 0.75% (Rx). The patent on the branded product by Galderma, which generates approximately $75 million in sales annually, expires today....
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Mumbai, 2 June 2006: Lupin Ltd. announced that the U.S. Food and Drug Administration (US FDA) has approved the Company’s Abbreviated New Drug Application (ANDA) for Cefdinir Suspension 125mg/5mL. Cefdinir is a third generation cephalosporin administered orally to treat a wide variety of bacterial infections....
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Apotex v. FDA, No. 06-5105 (D.C. Cir. June 6, 2006)
The Court of Appeals for the D.C. Circuit today upheld an FDA rule stating that a district court order dismissing a patent suit for lack of subject matter jurisdiction is not a court decision under the Hatch-Waxman Act, and is therefore insufficient to trigger the first ANDA filer's 180-day exclusivity period....
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ALLEGAN, Mich., June 7 (UPI) -- Perrigo said Wednesday it has signed a deal with Dexcel Pharma for over-the-counter marketing of Dexcel's generic Prilosec OTC....
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Gurgaon, India, June 07, 2006 - Ranbaxy Pharmaceuticals Inc. (RPI) a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL) announced today that RPI has entered into an agreement with Zenotech Laboratories Ltd. (Zenotech Labs) of Hyderabad, India. Based on the agreement, Zenotech Labs will develop, submit for regulatory approval, and manufacture a total of 11 oncology products which Ranbaxy will market as generic formulations in the U.S. and Canada under the Ranbaxy label. The combined branded sales of these products is $3.7 billion ($US, IMS - MAT: March 2006)....
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A Federal Circuit panel of Judges Newman, Rader, and Prost heard oral arguments Monday in Integra LifeSciences v. Merck KGaA, No. 02-1052....
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Gurgaon, India, June 08, 2006 - Ranbaxy Laboratories Ltd (Ranbaxy) announced today the completion of the acquisition of a 96.7 % stake by Ranbaxy Netherlands BV in the leading Romanian pharmaceutical company Terapia S.A. (Terapia) following the approval by the Romanian Competition Council (RCC)....
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PHOENIX (June 9, 2006) – Synovics Pharmaceuticals, Inc., specialty pharmaceutical company with proprietary technologies for the development of controlled-release generic and branded oral drugs, today announced that its wholly owned subsidiary, Synovics Laboratories, Inc., has initiated the process for U.S. chemical, manufacturing and control (CMC) development of its third controlled-release generic drug candidate, SNG1003....
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Gurgaon, India, June 09, 2006 - Ranbaxy Laboratories Limited (RLL) announced today that the Company plans to market Zonisamide Capsules for the treatment of epilepsy in the U.S. market through a strategic partnership with Invagen Pharmaceuticals Inc. (Invagen) of Hauppauge, New York. Invagen has received the U.S. FDA approval for bio-equivalency and, therefore a therapeutically equivalent Zonisamide to the listed drug Zonegran(tm) Capsules, 25mg, 50mg, and 100mg respectively....
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WOODCLIFF LAKE, N.J., June 12 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its Barr Laboratories, Inc. subsidiary has entered into an agreement to settle litigation claims made by Invamed, Inc. and Apothecon, Inc., both of which have since been acquired by Sandoz, Inc., a subsidiary of Novartis AG (NYSE: NVS), regarding the raw material source for Warfarin Sodium. The agreement terminates the on-going litigation between the parties....
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SAINTE-FOY, QUEBEC--(CCNMatthews - June 13, 2006) - Bioxel Pharma Inc. (TSX VENTURE:BIP), a leading manufacturer and supplier of taxane APIs and developer of targeted oncology drugs, is pleased to announce that six new generic pharmaceutical companies will list Bioxel's paclitaxel API in their registration dossier; bringing to eight the number of EU countries for which its paclitaxel API can be used in commercial generic drugs....
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In a ruling of great potential usefulness in the defense of pharmaceutical litigation, a federal district court in Pennsylvania (Baylson, J.) on May 25, 2006 dismissed a lawsuit claiming that alleged inadequate warnings accompanying the anti-depressant prescription medication Paxil and/or its generic equivalent had led to the suicide of plaintiff’s wife. The court held that plaintiff’s state law failure-to-warn claims were impliedly preempted by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq. (hereinafter, the Act)), and the regulations promulgated under the Act by the United States Food and Drug Administration (FDA)....
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Pharmaceutical and biotechnology major Wockhardt Limited has received US FDA’s tentative approval for Divalproex Sodium delayed release tablets, making it the company’s first product incorporating NDDS (novel drug delivery system) to be cleared for sale in the US....
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Jerusalem, Israel,, June 14, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U. S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Losartan Potassium and Hydrochlorothiazide Tablets, 50 mg/12.5 mg and 100 mg/25 mg. Final approval is expected upon expiration of patent protection in April 2010....
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PLIVA announced today the opening of its new Research and Development facility PLIVA Research (India) Private Ltd., in GOA, India, the fourth R&D; center within the Group. The GOA center will be focused on conducting bioequivalence, bioavailability and pharmacokinetic studies for the company's generics product pipeline and will complement PLIVA’s existing R&D; capabilities established in the areas of chemistry, biotechnology and formulation development, already operating in Croatia, Poland and the Czech Republic....
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Final Approval and Launch Expected to Occur Later This Year Following Expiration of Pediatric Exclusivity Period
DEERFIELD, Ill., June 15, 2006 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation today announced that it has received tentative approvals from the U.S. Food and Drug Administration (FDA) for Ondansetron Injection USP, including the first tentative approval for a premix version of GlaxoSmithKline's Zofran(R), which is used for the prevention of nausea and vomiting....
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On June 17, 2006, proposed amendments to the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) and to the data protection provision of the Food and Drugs Regulations were published. The new proposals replace earlier proposed amendments, which were published on December 11, 2004 but were not adopted....
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In a case of first impression, the U.S. District Court for the Southern District of New York held, on cross motions for summary judgment regarding available remedies, that an Orange Book listing of patents protecting an approved drug was not effective public notice under the patent marking statute, 35 U.S.C. 287(a). Merck & Co. v. Mediplan Health Consulting, No. 05 Civ. 3650 (S.D.N.Y. June 14, 2006). As a result, the damages available to Merck were limited to those accruing after the date on which the lawsuit was filed, rather than those accruing after the date on which Merck listed the patent in suit in the Orange Book....
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The FTC last week filed a supplemental brief in the Supreme Court, in response to the Solicitor General's brief, in FTC v. Schering. The case involves the legality of reverse payment settlements--those from an innovator drug company to a generic drug company--in Hatch-Waxman cases. The Solicitor General, whose views on the case were requested by the Supreme Court, argued in his brief last month that the Court should deny FTC's petition for certiorari. Now, in its supplemental brief, the FTC takes issue with many of the Solicitor General's arguments....
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From Duncan Bucknell - www.DuncanBucknell.com
(Merck & Co Inc v Arrow Pharmaceuticals Limited [2006] FCAFC 91)
Take home
On 15 June 2006, the Full Federal Court of Australia handed down its judgment in Merck & Co Inc v Arrow Pharmaceuticals Limited [2006] FCAFC 91.
Under Australian law, a patent specification which incorporates by reference the entire disclosure of one or more prior art documents is more likely to be invalidated for lacking a manner of new manufacture.
The classic test for the required degree of disclosure in a prior art reference was reiterated by the Full Court – would a skilled addressee have been able to at once perceive, understand, and be able practically to apply the discovery without the necessity of making further experiments?...
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Recent disputes between research-based pharma companies and generics have addressed the viability of use patents in PMNOC proceedings. Bill Richardson of McCarthy TĂ©trault LLP examines the cases and asks whether the Regulations need to be changed.
A paradigm shift in patent law?...
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JERUSALEM, Israel--(BUSINESS WIRE)--Jun 19, 2006 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's Proscar(R) (Finasteride) Tablets, 5 mg. Shipment of this product will begin immediately....
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HAIKOU CITY, Hainan Province, China, June 19, 2006 /Xinhua-PRNewswire/ -- China Pharma Holdings announced that it had recently received approvals from China's State Food and Drug Administration (SFDA) to manufacture and market three new generic products: Ozagrel, Propylgallate and Alginic Sodium Diester. All three drugs are by prescription only and will be available as injectable forms....
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ARLINGTON, Va., June 20 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today praised action by the Senate Agricultural Appropriations Subcommittee, that will, if ultimately approved, provide an additional $10 million in funding for the Office of Generic Drugs (OGD). The increase is included in the Subcommittee's fiscal 2007 Department of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill. GPhA, which has championed the need for increased funding, said the increase would provide long-lasting dividends to all health care purchasers and health care programs, by speeding the approval of more affordable generic pharmaceuticals....
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SAO PAULO, Brazil, June 21 /PRNewswire/ -- The EMS-SIGMA PHARMA Group announces a technical-scientific agreement with the Italian MonteResearch Pharmaceutical Development Service. The investment reaches 7 million euros. With this contract, the Group intends to increase its share in the European market, where it has been operating since 2004 through the Portuguese company Germed, and continue offering Brazilians efficient, safe medicines....
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Suit alleged Nicomide patent was Invalid
DUSA files Amended Complaint in New Jersey
WILMINGTON, Mass. - June 21, 2006 - DUSA Pharmaceuticals, Inc. announced today that on June 19th, 2006 the United States District Court for the Northern District of Georgia, Gainesville Division, dismissed all claims alleged by River's Edge Pharmaceuticals, LLC in its lawsuit against DUSA and its wholly-owned subsidiary, Sirius Laboratories, Inc. The lawsuit was filed by River’s Edge on March 28, 2006, alleging, among other things, that Sirius agreed to authorize River's Edge to market a generic version of Nicomide®, and that the United States patent covering Nicomide® issued to Sirius in December, 2005 is invalid....
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Jerusalem, Israel, June 22, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the United States Court of Appeals for the Federal Circuit has vacated a June 2005 ruling by the U.S. District Court for the Northern District of Illinois, which had granted Abbott's motion for a preliminary injunction related to Teva's generic Biaxin® (Clarithromycin) XL Filmtabs®....
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HARTFORD, Conn., June 22, 2006 — Aetna Pharmacy Management (APM) today announced it will encourage members to use generics first when the patent for Zocor expires this Friday. Aetna is supporting Teva Pharmaceuticals (NASDAQ: TEVA), which manufactures the generic alternative Simvastatin, to help provide customers with continued access to affordable, appropriate prescription drug benefits and bring the generic product to market....
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The Food and Drug Administration (FDA) granted tentative approval on June 22, 2006 for generic lamivudine - oral solution, 10 mg/mL manufactured by Cipla Limited, Mumbai, India. This action represents the second tentative approval of a generic version of the already FDA approved Epivir Oral Solution, 10 mg/mL, manufactured by GlaxoSmithKline. This child-friendly-product is indicated for use in pediatric patients with HIV from three months to 16 years....
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Cholesterol-Lowering Simvastatin Currently Marketed in the U.S. as Zocor®
Gurgaon, Haryana, India - June 23, 2006 - Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Simvastatin Tablets USP, 80mg with 180-day exclusivity in the U.S. The FDA's Office of Generic Drugs has determined Ranbaxy's 80mg Simvastatin Tablets USP, to be bioequivalent, therefore, therapeutically equivalent to the listed drug Zocor® Tablets, 80mg, of Merck Research Laboratories....
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Mumbai, 23 June 2006 : Lupin Pharmaceuticals, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Quinapril Tablets USP in 5 mg, 10 mg, 20 mg and 40 mg strengths....
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Hyderabad, India, June 23, 2006: Dr. Reddy’s Laboratories today announced that it has launched the authorized generic version of Merck’s Proscar® tablets 5mg (finasteride) on June 19, 2006. The Company has also launched the authorized generic version of Merck’s Zocor® tablets (simvastatin) 5mg, 10mg, 20mg, 40mg and 80mg on June 23, 2006....
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FAJARDO, Puerto Rico, June 23 /PRNewswire/ -- Warner Chilcott Company, Inc. announced today that it has received a Paragraph IV Certification Notice from Watson Laboratories, Inc. advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of LOESTRIN(R) 24 FE....
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PARIS, NEW YORK and TORONTO, June 25 /PRNewswire-FirstCall/ -- Sanofi- aventis and Bristol- Myers Squibb and Apotex Inc. and Apotex Corp. today announced that in response to concerns raised by the Federal Trade Commission (FTC) and state attorneys general to the previously announced proposed settlement the companies reached with Apotex relating to patent infringement litigation on Plavix® (clopidogrel bisulfate), the companies and Apotex have amended the agreement. Review of the modified agreement by the FTC and state attorneys general continues....
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The FDA recently appealed the district court case that forced it to make a decision on Sandoz's drug application for Omnitrope, which later led to FDA to approve Omnitrope. Sandoz has called Omnitrope the first ever biogeneric drug....
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Jerusalem, Israel, June 25, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's Zocor® (Simvastatin) Tablets, 5 mg, 10 mg, 20 mg, and 40 mg. Shipment of these products has commenced....
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Jerusalem, Israel, June 25, 2006 - Teva Pharmaceutical Industries Ltd. announced today that Novartis' generic unit, Sandoz, Inc., has filed a complaint in the United States District Court for the District of Columbia, seeking approval of its generic Zocor® products in the face of an April 30, 2006 decision of the same Court....
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Today, the US Supreme Court refused to become involved in a closely watched case that tested the legality of multimillion-dollar settlements between big pharma drug companies and their generic rivals. The issue in that case was whether these big drug companies – such as Schering-Plough, the company involved in the case – should be allowed to pay generic rivals to stay out of the market in order to settle patent challenges. Schering-Plough has repeatedly maintained that these types of patent settlements are legal....
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In response to the Supreme Court's denial of certiorari in FTC v Schering earlier this week, four senators introduced Senate bill S3582 yesterday, which seeks to prohibit brand name drug companies from entering into reverse payment settlements with generic drug companies. In FTC v. Schering, the FTC had petitioned the Court to decide whether a reverse payment settlement from Schering to generic drug makers was in violation of antitrust laws. Denial of certiorari by the Supreme Court left standing an Eleventh Circuit decision holding that the settlement did not violate antitrust laws....
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ROCKVILLE, Md., June 28, 2006--The Food and Drug Administration, on June 27, 2006, granted tentative approval for stavudine 15 and 20 mg capsules manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India. Tentative approval was granted to the same manufacturer for generic stavudine, 30 and 40 mg capsules on July 1, 2005, and for Oral Solution, 1 mg/mL on December 21, 2006....
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FORT LAUDERDALE, Fla. & CORONA, Calif.--(BUSINESS WIRE)--June 28, 2006--Andrx Corporation and Watson Pharmaceuticals, Inc. announced that, at a Special Meeting of Stockholders held today, Andrx's stockholders adopted the agreement and plan of merger that Andrx entered into with Watson Pharmaceuticals, Inc. and its wholly owned subsidiary on March 12, 2006, providing for the acquisition of Andrx by Watson....
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ARLINGTON, Va., June 28 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today issued the following statement in response to a news release issued by PhRMA on its study assessing the practice of authorized generics in the United States....
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London, U.K., June 28, 2006/Gurgaon, Haryana, India - June 28, 2006 - Ranbaxy Laboratories Limited (Ranbaxy) today acknowledged that the U.K. Court of Appeal has handed down a decision upholding the U.K. High Court of Justice's ruling from October 12, 2005, in Ranbaxy's case against (Pfizer) Warner-Lambert over the cholesterol-lowering drug, atorvastatin, which is marketed by Pfizer as Lipitor®....
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Actavis Group, the international generic pharmaceuticals company, notes Tuesday's announcement from PLIVA recommending a HRK 705 per share proposal from Barr Pharmaceuticals Inc. Actavis announces that it submitted an improved proposal to PLIVA and its financial advisers on Monday 26 June and now confirms the terms of that proposal today....
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On Thursday, Pfizer announced that it plans to introduce a generic version of its antidepressant Zoloft in the United States as soon as a rival generic hits the market, which could be as early as Saturday (in what is known as the sale of an “authorized generic”). The patent on Zoloft expires in two days....
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Jerusalem, Israel, June 29, 2006 - Teva Pharmaceutical Industries Ltd. announced today that it launched Teva's generic Biaxin® (Clarithromycin) XL Filmtabs® last Friday following the decision rendered on Thursday June 22, 2006 by the U.S. Court of Appeals for the Federal Circuit vacating a June 2005 ruling which had granted Abbott's motion for a preliminary injunction related to the product....
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HAYWARD, Calif.--(BUSINESS WIRE)--June 29, 2006--IMPAX Laboratories, Inc. announced today it has settled a suit brought against it in 2003 by Solvay Pharmaceuticals, Inc. alleging that IMPAX engaged in false advertising practices dating back to 1998 in connection with the marketing of two of the Company's ten Lipram pancreatic enzyme supplements as well as two discontinued pancreatic enzyme supplements....
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ALLEGAN, Mich., June 29, 2006 /PRNewswire-FirstCall/ -- The Perrigo Company today announced that its partner, Kali Laboratories, Inc., a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. , has received tentative approval from the U.S. Food and Drug Administration (FDA) on its ANDA for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base)....
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SPRING VALLEY, N.Y., June 30, 2006 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that its wholly-owned subsidiary, Kali Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for tranylcypromine sulfate tablets, 10 mg. Tranylcypromine is the generic version of GlaxoSmithKline's Parnate(R) and is used for the treatment of depression. Annual U.S. sales of Parnate(R) exceed $6 million. Par will begin shipping the product immediately....
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Gurgaon, Haryana, India - June 30, 2006 - Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Cefprozil for Oral Suspension USP, 125 mg/5mL and 250 mg/5mL. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Cefzil® for Oral Suspension by Bristol Myers Squibb Company Pharmaceutical Research Institute. Total annual market sales for Cefprozil were $93 million (IMS - MAT: March 2006)....
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Jerusalem, Israel, June 30, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer's Zoloft® (Sertraline) Tablets, 25 mg, 50 mg, and 100 mg....
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EXTON, Pa., June 30 /PRNewswire-FirstCall/ -- ViroPharma Incorporated today submitted a supplement to its Petition for Stay of Action with the FDA regarding the bioequivalence requirements for abbreviated new drug applications (ANDAs) that seek to copy Vancocin capsules. The document sets forth scientific arguments supporting ViroPharma's strong belief that the decision of the FDA's Office of Generic Drugs (OGD) to modify the bioequivalence standards for generic copies of Vancocin capsules is scientifically flawed....
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