Zithromax

JERUSALEM — Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Columbia has granted Teva’s motion for summary judgment on the issue of whether Ivax’s Abbreviated New Drug Application (ANDA) to market a generic version of Merck’s Zocor(R) (Simvastatin) Tablets, 10, 20, and 40 mgs is entitled to 180-day Hatch-Waxman statutory exclusivity. The Court found unlawful the FDA’s October 24, 2005 decision denying Ivax’s citizen’s petition on the exclusivity issue and, accordingly, has remanded the matter back to the FDA.

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Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Close to 90% of Teva’s sales are in North America and Europe.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Tevas future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to Teva’s ability to rapidly integrate Ivax Corporation’s operations and achieve expected synergies, Tevas ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called “authorized generics”) or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra(R), Neurontin(R), Oxycontin(R) and Zithromax(R), the effects of competition on Copaxone(R) sales, including as a result of the expected reintroduction of Tysabri(R) into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva’s ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva’s Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
COPYRIGHT 2006 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

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The Centers for Disease Control and Prevention recently published revised guidelines for the prevention and treatment of sexually transmitted diseases. One new treatment strategy is the use of azithromycin as a primary, rather than alternative, medication for pregnant women with Chlamydia trachomatis infection. Quinolone-resistant Neisseria gonorrhoeae infection continues to increase in the United States; therefore, quinolones are no longer recommended for treatment of this infection. Expedited partner therapy gives physicians another option when addressing the need to treat partners of persons diagnosed with N. gonorrhoeae or C. trachomatis infection. Tinidazole is now available in the United States and can be used to manage trichomoniasis, including trichomoniasis resistant to metronidazole. Shorter courses of antiviral medication can be used for episodic therapy of recurrent genital herpes. Because of increasing resistance, close follow-up is required if azithromycin is used as an alternative treatment in the management of primary or secondary syphilis. Unexpected increases in the rates of lymphogranuloma venereum have occurred in the Netherlands, and physicians should remain vigilant for symptoms of this disease in the United States. (Am Fam Physician 2007;76:1827-32, 1833-34. Copyright [C] 2007 American Academy of Family Physicians.)

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The centers for Disease control and Prevention (CDC) recently released updated guidelines for the prevention and treatment of sexually transmitted diseases (STDs).1 These guidelines were developed through a systematic review of evidence that has become available since the 2002 guidelines were issued, as well as through expert consultation.
Health Education
Education and counseling are the main strategies in the prevention and control of STDs. evaluation includes addressing key areas of sexual health referred to as the Five P’s: Partners, Prevention of pregnancy, Protection from STDs, Practices, and Past history of STDs. Addressing this information with patients creates an opportunity for physicians to provide counseling and education while taking into account each patient’s individual risk factors and goals. The use of motivational interviewing focuses on the specific behaviors of the patient and places a greater emphasis on moving toward individually defined, achievable, risk-reduction goals. Table 1 (1) lists symptoms and diagnoses of selected STDs.
A visit with a physician for the screening, diagnosis, or treatment of STDs also provides an opportunity for the physician to educate the patient about human immunodeficiency virus (HIV). Patients may not be aware that the presence of an STD may facilitate the transmission of HIV if they are exposed to the virus. Because some patients who are HIV positive are unaware of their diagnosis, the CDC now encourages HIV screening for patients in all health care settings. Although patients may choose not to be tested, written consent for testing is no longer recommended (unless mandated by the state). (2)
Chlamydia Trachomatis
Chlamydia trachomatis is the most common reportable infectious disease in the United States, with almost 1 million cases reported in 2004. (3) Few recommendations have changed for the treatment of persons infected with C. trachomatis; however, azithromycin (Zithromax) is now recommended as a primary, rather than alternative, treatment in pregnant women (Table 2). (1) This change occurred because of recent evidence supporting azithromycin as safe and effective during pregnancy. (4-6)
Neisseria Gonorrhoeae
Since the publication of the 2002 STD treatment guidelines, the rate of quinolone-resistant Neisseria gonorrhoeae has continued to increase throughout the United States. As resistance increases, recommendations continue to change. Previous recommendations focused on the high levels of resistance in areas of Asia and the Pacific, California, Hawaii, and in some specific populations in the United States (e.g., men who have sex with men). In 2004, 6.8 percent of isolates collected by the CDC’s Gonococcal isolate Surveillance Project were resistant to ciprofloxacin (cipro); when samples from California and Hawaii were excluded, 3.6 percent of isolates were resistant. (7)
Quinolone-resistant N. gonorrhoeae is more common in men who have sex with men than in men who have sex exclusively with women (23.8 versus 2.9 percent, respectively) (7); however, the rate of quinolone-resistant N. gonorrhoeae continues to increase among heterosexual persons. In heterosexual men, the prevalence rose from 0.9 percent in 2002 to 3.8 percent in 2005, (8) and preliminary data from the first six months of 2006 indicate an increase to 6.7 percent. (9) Current guidelines reflect these changes (Table 3 (1)) by no longer recommending quinolones as treatment for N. gonorrhoeae infection. (9)
Expedited Partner Treatment
It is standard practice to recommend that sex partners of patients diagnosed with an STD be treated to decrease the risk of reinfection and to decrease the incidence and prevalence of STDs among social networks. The primary goal is for the patient’s sex partners to be seen by a physician for testing, treatment, and education. however, there may be clinical situations in which this cannot be accomplished (e.g., because of patient, partner, or resource limitations). In these circumstances, the CDC recommends that physicians consider using expedited partner treatment.

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A generic version of Zithromax (azithromycin) is now available for injection in a 500-mg vial for the treatment of patients who need intravenous therapy for infections caused by susceptible strains of designated microorganisms in community-acquired pneumonia and pelvic inflammatory disease. For more information, contact Barr Laboratories Inc. by calling 800-222-0190.

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COPYRIGHT 2007 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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JERUSALEM — Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company’s Topiramate Tablets, 50 mg. Teva previously received tentative approval for the 25 mg, 100 mg and 200 mg strengths of this drug product. Final approval is anticipated upon expiry of patent protection in September 2008.
Upon final approval, Teva’s Topiramate Tablets will be the AB-rated generic equivalent of Ortho McNeil’s anticonvulsant Topamax(R) Tablets.

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Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Close to 90% of Teva’s sales are in North America and Europe.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Tevas future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to Pfizer’s claims regarding Teva’s Azithromycin product, Teva’s ability to rapidly integrate Ivax Corporation’s operations and achieve expected synergies, Tevas ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell or license their own generic products under generic trade dress and at generic prices (so called “authorized generics”) or seek to delay the introduction of generic products, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final court decision, including that relating to the generic versions of Allegra(R), Neurontin(R), Oxycontin(R) and Zithromax(R), the effects of competition on Copaxone(R) sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Tevas ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations outside the United States that may be adversely affected by terrorism or major hostilities, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva’s Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
COPYRIGHT 2006 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

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Baxter Healthcare Corp. has brought out a generic version of Pfizer Inc.’s Zithromax. The launch of the injectable antibiotic marks the first time that Baxter has been granted market exclusivity by an innovator firm.

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COPYRIGHT 2006 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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Teva Pharmaceuticals, Inc., has received FDA approval to manufacture generic versions of Pfizer Inc.’s Zithromax. Pfizer is also planning to provide generic versions of Zithromax through its Greenstone Unit.

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COPYRIGHT 2006 Journal of Drugs in Dermatology, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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VITAL SIGNS

Top 10 Drugs Prescribed by
Pediatricians in 2005

Singulair 4,556
Zithromax suspension 3,937
Omnicef 2,923
Concerta 2,904
Adderall XR 2,556
Zyrtec Syrup 2,353
Zyrtec 1,895
Advair Diskus 1,559
Pulmicort Respules 1,334
Zithromax Z-Pak 1,275

Note: Estimated data based on prescription drugs dispensed by retail
pharmacies throughout the United States.

Note: Table made from bar graph.

Source: Verispan

COPYRIGHT 2006 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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M2 PRESSWIRE-10 January 2007-Biotech News: Fundamental Review for Kosan Biosciences Inc(C)1994-2007 M2 COMMUNICATIONS LTD RDATE:10012007 Fundamental Review for Kosan Biosciences Inc (NASDAQ:KOSN) Kosan Biosciences is manipulative — but in a good way. The development-stage firm alters naturally occurring polyketides to produce new classes or improve upon existing classes of pharmaceuticals.

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Polyketides are produced by microorganisms and used to make such drugs as Zithromax, an antibiotic from Pfizer, and Pravachol, a cholesterol fighter from Bristol-Myers Squibb. Kosan targets …

Read the rest of this article with a Free Trial at HighBeam Research.

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Chlamydia trachomatis is a bacterium, sexually transmitted infection that can trigger main spoil to the female reproductive organs if not diagnosed and treated effectively. In the United States this genital infection occurs frequently among sexually active immature persons.People who are infected with chlamydia may not have any symptoms.According to www.womenshealth.about.com, chlamydia affects over 3 million people per year, and three out of four of these people are under the age of 25 existence. An overwhelming 50% of women have had chlamydia before they reached the age of 30. The symbols of symptoms of chlamydia may be absent or only somewhat noticeable, and if Chlamydia medicine is not required quickly enough, rigorous scratch can happen to the ovaries, Fallopian tubes, and uterus, causing infertility. Many women who have required chlamydia action in the onwards may not even know that their reproductive organism has been precious until they are incapable to get pregnant. Chlamydia anxiety generally does not include scrutiny the task of the reproductive organs, and is only discovered when these women take conduct for infertility.About 75% of infected women and half of infected men have no symptoms of the disease (STD). If symptoms submit, it may be abnormal discharge or agonizing urination, both of which can be very thin. Often period Chlamydia has progressed far enough that some hurt has already occurred because action was not started quicker. These chlamydia treatments typically consist of prescription antibiotics, such as Zithromax, tetracycline, or erythromycin, all antibiotics that are actual in slaughter chlamydia with only a few doses. Patients should be instructed to kill prescribed chlamydia treatments even if symptoms are no longer stage. zanaflex. Other the STD may not be fully eradicated and come back with vengeance, requiring more chlamydia therapy with an even stronger antibiotic.This infection is curable, chlamydia can be transmitted during vaginal, anal, and, oral sex even if the penis or tongue does not enter the vagina, chops, or rectum.The only way to duck having to take chlamydia healing is to use a barrier plan, such as a condom during intercourse. If you dont know your partner that well, or there are extramarital relationships occurring, then by all means use a condom just to be reliable. You may never know, especially if you are free and having one night stands and engaging in other promiscuous sexual activities. If you do shrivel the bug, then request difficult and chlamydia cure when possible. You may be too embarrassed to seek chlamydia dealing, which is understandable, but at the same time, your reproductive vigor is at stake. Confide in your strength care bringer if you have engaged in unprotected sex, and get veteran. You may not have Chlamydia, but you will feel much better eloquent that, and if you do, you can plus chlamydia handling right away. Chlamydia can be simply treated with antibiotics. Make positive your sex partner(s) also grasp treatment and forestall having sex while being treated not getting the infection again and transmitting it again.
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