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Teva’s clarithromycin extended-release tablets are the AB-rated generic equivalent of Abbott’s macrolide antibiotic Biaxin XL Filmtabs. The brand product has annual sales of approximately $284 million. Teva also received final approval for its ANDA for fenofibrate tablets, 54 mg and 160 mg, the AB-rated generic equivalent of Abbott’s Tricor tablets indicated for the treatment of hypercholesterolemia and hypertriglyceridemia.
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“We’re disappointed that the Canadian Supreme Court declined to hear our appeal,” Scott Stoffel, an Abbott spokesman, said. “The company will continue to vigorously defend its intellectual property.” Biaxin generated $816 million …

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In 1994, a National Institutes of Health consensus panel of medical experts made a landmark recommendation in support of an antibiotic-based approach for treating ulcers. FDA used the recommendation to advise companies on the best trial designs for developing these therapies.
In one foreign and two U.S. randomized studies, the most effective dosage levels were Biaxin at 500 milligrams three times a day plus Prilosec at 40 mg once a day for two weeks, followed by Prilosec at 20 mg once a day for two more weeks.
Although study participants reported few side effects, mild to moderate cases of taste distortion, nausea, headache, diarrhea, vomiting, and abdominal pain did occur.
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Non-interest income grew to $88,000 from $80,000 in 1999. The holding company for Fairfield Savings Bank said it hired management consultants John M. Floyd and Associates to make recommendations to improve profitability. Abbott seeks new Biaxin use LIBERTYVILLE TOWNSHIP - Abbott …

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It is also indicated for mild to moderate infections in adults with acute bacterial exacerbation of chronic bronchitis.
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COPYRIGHT 2008 Gale, Cengage Learning

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TREATMENT
Erythromycin, clarithromycin (Biaxin), and azithromycin (Zithromax) are preferred for the treatment of pertussis in persons one month and older. In thoses younger than one month, the use of erythromycin and clarithromycin is not recommended, and azithromycin is preferred. For patients two months and older, an alternative agent, trimethoprim/sulfamethoxazole (TMP/SMX [Bactrim, Septra]), is available.
When choosing an antimicrobial for treatment or prophylaxis, the following factors should be taken into account: effectiveness, safety, tolerability, ease of adherence, and cost. Azithromycin and clarithromycin are as effective as erythromycin for treatment of pertussis in patients six months and older. They also are better tolerated and are associated with fewer and milder side effects than erythromycin. However, erythromycin is available in generic form and is less expensive.
POSTEXPOSURE PROPHYLAXIS
If there is no contraindication, a macrolide can be given as prophylaxis for persons who are in close contact with a patient who has pertussis. Before making a decision about postexposure chemoprophylaxis, the following factors should be evaluated: infectiousness, degree of exposure, potential consequences of severe pertussis in the contact, and possibilities for secondary exposure of persons at high risk (e.g., those younger than 12 months). Benefits should be weighed against the potential side effects of the drug.
Giving postexposure prophylaxis to asymptomatic household contacts within 21 days of the original patient’s cough onset can prevent symptomatic infection. Symptomatic household members should be treated as if they have pertussis. Postexposure prophylaxis should be administered in infants younger than 12 months or women in the third trimester of pregnancy, because they are at risk for severe and possibly deadly complications. The recommended antimicrobial agents and dosages for postexposure prophylaxis are the same as those for the treatment of pertussis (Table 1).
SPECIAL CONSIDERATIONS
The U.S. Food and Drug Administration has not approved any macrolide for use in infants younger than six months. Information regarding the safety and effectiveness of azithromycin and clarithromycin use in this age group is limited.
Small clinical studies propose that azithromycin and clarithromycin are similarly effective in patients one to five months of age and in older infants and children. These limited trials support the use of azithromycin and clarithromycin as first-line agents in infants one to five months of age. This is because of their in vitro effectiveness against B. pertussis, their more convenient dosing, and their recognized safety and effectiveness in older children and adults. However, it should be noted that untreated infants with pertussis remain culture-positive for a longer duration than older children and adults.
SAFETY
A macrolide is contraindicated if there is a history of hypersensitivity. The common side effects of oral macrolides are gastrointestinal (e.g., nausea, vomiting, abdominal pain and cramps, diarrhea, anorexia) and rashes. Side effects are more common and severe with erythromycin therapy.
Specific Antimicrobial Agents AZITHROMYCIN
Azithromycin is administered as a single daily dose, and it is classified as a Pregnancy Category B drug. Because they reduce absorption of azithromycin, antacids containing aluminum or magnesium should not be used by patients taking azithromycin. Physicians should be cautious about prescribing to patients with impaired hepatic function, and patients should be monitored if they also use agents that are metabolized by the cytochrome P450 enzyme system or other drugs for which pharmacokinetics change (e.g., digoxin, triazolam [Halcion], or ergot alkaloids). Possible side effects of azithromycin use include abdominal discomfort or pain, diarrhea, nausea, vomiting, headache, and dizziness.
ERYTHROMYCIN
A 14-day course of erythromycin is recommended because relapses have been reported after completion of a seven-to 10-day treatment regimen. Erythromycin is classified as a Pregnancy Category B drug. Although animal reproduction studies have not demonstrated a risk to the fetus, no sufficient or well-controlled trials in humans exist.

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The reformulation of clopidogrel bisulfate is an example of the potential for Acusphere’s proprietary Hydrophobic Drug Delivery System (HDDS[TM]) technology to create intravenous formulations of drugs that are currently only available in oral dosage form. In a hospital setting, intravenous formulations can be desirable because rapid onset of action is especially important in acute situations, and many patients are unable to take oral medications. Many drugs are hydrophobic and only available in oral dosage form, and some have generated revenue of over $1 billion in annual worldwide revenues, such as Biaxin[R], Celebrex[R], Coreg[R], Norvasc[R] and Plavix[R]. The Company has demonstrated, in multiple laboratory tests that its technology has the potential to enable the intravenous formulation of drugs currently available only in oral form in a wide variety of drug classes, including antibiotics, non-steroidal anti-inflammatory drugs, anti-platelets and anti-hypertensives. Some of these new formulations, if commercialized, could potentially fit into the acute care commercial infrastructure that the Company is developing to support its lead product candidate, Imagify[TM] (perflubutane polymer microspheres) injectable suspension. Acusphere plans to announce such a new development program later this quarter.
“Clopidogrel bisulfate is a particularly challenging drug to formulate for intravenous delivery because it is not only hydrophobic but it is also an oil under conditions appropriate for administration,” stated Howard Bernstein, M.D., Ph.D., Acusphere’s Executive Vice President of Research and Development. “These findings further demonstrate the breadth of our proprietary technology’s ability to create intravenous formulations of even the most difficult to formulate drugs.”
About Acusphere, Inc.
Acusphere (NASDAQ: ACUS) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. The Company is focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Its lead product candidate, Imagify[TM] (perflubutane polymer microspheres) injectable suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States. In May 2007 the Company announced the results of its Phase 3 clinical program for Imagify. It is currently working towards submitting an NDA (New Drug Application) for Imagify. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary artery disease. It is estimated that over 10 million procedures are done each year in the U.S. to detect coronary artery disease, the leading cause of death in the United States. The Company estimates that the potential annual U.S. market opportunity for Imagify exceeds $2 billion. Imagify and the Company’s other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company’s web site at www.acusphere.com. “Acusphere” and “Imagify” are trademarks of Acusphere, Inc.
Forward-looking Statements
The above press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, including statements concerning the technical capabilities of the Company’s microparticle technology and the commercial prospects for the same, the Company’s intention of commencing and announcing a new development program for this technology later this year, the timing and ability of the Company to file an NDA for its lead product Imagify and the ability of the Company to successfully commercialize Imagify and develop an infrastructure to support such commercialization. There can be no assurance that the FDA will accept the Company’s NDA for Imagify or that Imagify will be approved for the indication the Company is seeking, or at all. The Company’s actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research and development, especially those involving new and untested technologies, uncertainties associated with regulatory approvals, especially uncertainties regarding regulatory evaluation of the Company’s statistical analysis plan and clinical trial results for Imagify and uncertainties regarding the potential affects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, future capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company’s commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, and other risks and challenges detailed in the Company’s filings with the U.S. Securities and Exchange Commission, including the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.
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After a drug is on the market, the FDA evaluates reports of safety problems on an ongoing basis. Experts consider such factors as the frequency and seriousness of the problems reported, as well as the seriousness of the disease the drug is meant to treat and whether alternative therapies are available.
“As we find out more about the potential risks or benefits of a drug,” Kweder says, “the label may be revised so that it better reflects information on appropriate use of the drug.”
The Drug Safety Oversight Board
The FDA’s Drug Safety Oversight Board (DSB) was formed in 2005 to make recommendations to the CDER about the management of emerging drug safety issues and to assist in communicating those issues to patients and physicians.
CDER Deputy Director Douglas C. Throckmorton, M.D., serves as chairman of the board. Susan Cummins, M.D., M.P.H., who worked previously in the FDA’s Division of Pediatric Drug Development, is the board’s executive director. The DSB also includes members from throughout the CDER, as well as experts from other parts of the FDA, the Department of Veterans Affairs, and the National Institutes of Health.
“The board adds an independent perspective to the decision-making process,” Kweder says. “It’s made up of FDA experts who were not involved in the initial review of the drug, as well as medical experts from other federal agencies.” Where appropriate, the DSB can also consult with experts outside of government and representatives of patient and consumer groups.
The DSB is charged with conducting timely and comprehensive evaluations of complex safety issues and with making recommendations to the CDER on how they should be managed and communicated to the public. Members meet roughly every six weeks to discuss emerging drug safety issues and to assist in developing safety policy in the CDER.
An important aspect of their work is weighing the impact of adverse drug reactions against the benefits of a drug, and how best to communicate that balance around emerging safety concerns–even when the FDA is still evaluating data and has not reached a conclusion. “All of these activities help the CDER communicate emerging safety concerns effectively to patients and physicians,” Throckmorton says. Some examples of drugs that the DSB has discussed include Tequin (gatifloxacin). In February 2006, after reports of patients who developed abnormal blood sugar levels from the use of Tequin, labeling changes were made to this antibiotic. The changes strengthened warnings about serious cases of low blood sugar and high blood sugar in people taking the drug. Also, a new contraindication was added; Tequin should not be used in people who have diabetes.
Trasylol (aprotinin injection). Trasylol is a drug used to prevent blood loss during surgery. In February 2006, the FDA issued a public health advisory alerting doctors who perform heart bypass surgery that Trasylol has been linked in two scientific publications to a higher risk of kidney problems, heart attacks, and strokes in those who undergo artery bypass graft surgery. The DSB agreed with this course of action, and the FDA has undertaken a full review of the available data before considering what additional steps, if any, are necessary.
Paxil (paroxetine). In December 2005, the FDA’s patient information sheet for the antidepressant Paxil was updated to indicate that early results of new studies show the drug increases the risk of birth defects, particularly in the first three months of pregnancy. Because of the risk of untreated depression, it was important to recommend that for some women who have already been taking the drug, the benefits of continuing the drug may be greater than the potential risks to the baby.
Biaxin (clarithromycin). The FDA’s patient information sheet for this antibiotic was updated in December 2005. A preliminary analysis of a study in Denmark of people with heart disease showed that clarithromycin use was associated with a higher chance of death from heart problems. After extensive internal analysis and discussion with the DSB, the FDA agreed with the conclusions of the Danish Medicines Agency and has not recommended any changes to the use of the drug at this time.
Evaluating Communication Tools
As part of the agency’s commitment to improving communications, the FDA held a public hearing on “CDER’s Current Risk Communication Strategies for Human Drugs” in December 2005, in Washington, D.C.