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From : SANKYO PHARMA INC December, 2002
Welchol® (colesevelam HCl) NO GENERIC EQUIVALENT NOTICE
Sankyo Pharma Inc. is writing to inform you that Welchol (colesevelam HCl, 625 mg Tablets) has no available generic equivalent. Therefore, the bile acid sequestrants cholestyramine and coletipol cannot be substituted for Welchol without prior approval from the prescribing physician.
Welchol is a non-systemic, lipid-lowering agent indicated as adjunctive therapy to diet and exercise for the reduction of elevated LDL-cholesterol (LDL-C) in patients with primary hypercholesterolemia (Frederickson Type IIa), when response to diet and exercise has been inadequate. Welchol is approved for monotherapy or in combination with any dose of any statin (HMG-CoA reductase inhibitor). The conventional bile acid sequestants cholestyramine and colestipol are no indicated for combination use with the statin class of drugs.
Clinical trials have demonstrated that Welchol is effective alone or in combination with any dose of any statin in reducing LDL-C and total cholesterol. Administration of Welchol at 3.8 g/day, which corresponds to six tablets (625 mg per tablet) is the recommended dose when given either as monotherapy or in combination with a statin.
The following points summarize the clinical utility of Welchol:
EFFICACY
In clinical trials, Welchol monotherapy resulted in statistically significant 15-18% mean reductions in LDL-C in patients, relative to placebo. These reductions in LDL-C occurred within 2 weeks following treatment initiation, and were maintained during long-term therapy.
Welchol is the only non-systemic lipid-lowering medication FDA approved for concurrent treatment with any dose of any statin.
In clinical trials, Welchol provided an additional 8-16% mean reduction in LDL-C when combined with a statin. The combination of Welchol and either atorvastatin, simvastatin, lovastatin was found to be statistically superior in decreasing mean LDL-C than monotherapy with either Welchol or the statin alone. Cholestyramine and colestipol have not been adequately studied in combination with statins in controlled clinical trials and are not indicated for such combination use.
Welchol (3.8 g/day), when combined with atorvastatin (10 mg/day) resulted in significant mean decreases in LDL-C (48%) and total cholesterol (31%), relative to placebo. These reductions in LDL-C were not statistically significantly different from those obtained with high-dose atorvastatin (80 mg/day) when given alone in this study.
Welchol (3.8 g/day) combined with simvastatin ( 10 mg/day) reduced mean LDL-C by 42 %, total cholesterol by 28% and increased median HDL-C by 10%, relative to placebo.
Safety
Liver function monitoring is not required during Welchol monotherapy. When Welchol is used in conjunction with a statin, no additional liver function monitoring is required beyond that which is routinely performed with the prescribed statin.
Welchol was well tolerated in clinical trials and has a favorable side effect profile. The most common side effects observed in clinical trials (>5%) were glatulence, constipation, infection, dyspepsia, and headache.
Combination treatment using Welchol (colesevelam HCl) and wither atorvastatin, simvastatin, or lovastatin, was not associated with an additive increase in adverse events.
In clinical studies, Welchol did not demonstrate significant pharmacokinetic interactions with respect to the absorption of lovastatin, quinidine, valproic acid, digoxin, warfarin, or metoprolol. Welchol decreased the maximum concentration (Cmax) and area under-the-curve (AUC) of sustained-release verapamil (Calan SR®, Pharmacia) by approximately 31% and 11% respectively. Since there is a high degree of variability in the bioavailability of vrapamil, the clinical significance of this finding is unclear.
ADMINISTRATION
Unlike cholestyramine and colestipol, Welchol (colesevelam HCl) does not need to be dosed hours apart from statins.
Welchol offers patient convenience. The Welchol recommended daily dose (6 tablets) may be taken QD of 3 tablets BID with meal(s) and a liquid, and may be administered at the same time as a statin. Cholestyramine and colestipol need to be dosed apart from other medications.
Please not that Welchol has not been evaluated when administered in combination with all medications. When administering Welchol with other drugs for which alterations in blood levels can have a clinically significant effect, consider monitoring drug levels consistent with standard protocols for those drugs.
The effects of Welchol, alone or in combination with a statin, on cardiovascular morbidity and mortality have not been determined.
Welchol is contraindicated in individuals with bowel obstruction and in individuals who have shown hypersensitivity to any of the components of Welchol. Caution should be exercised when treating patients with dysphagia, swallowing, disorders, severe gastrointestinal motility disorders, or major gastrointestinal tract surgery. Because Welchol was not tested in patients with triglycerides >300 mg/dL, caution should also be exercised when treating these patients. While Welchol did not induce any clinically significant reduction i the absorption of vitamins A, D, E, or K in clinical trials of up to one (1) year, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies. Welchol is classified as Pregnancy Category B.
As with all cholesterol-lowering agents, serum total-cholesterol, LDL-C, and triglyceride levels should be determined periodically based on current NCEP guidelines to confirm favorable and adequate long-term responses to Welchol.
Welchol is supplied as a single strength 625 mg tablet in bottles of 180 (NDC 65597-701-18)
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Dispense WelChol: Do Not Substitute
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Sankyo Pharma recommends that Welchol be used in full compliance with the approved prescribing information. For complete information concerning INDICATIONS and USAGE, CONTRAINDICATIONS, PRECAUTIONS, ADVERSE REACTIONS and DOSAGE and ADMINISTRATION for Welchol (colesevelam HCl), please consult the enclosed package insert.
I trust that you find this information to be of value. If you have additional questions about Welchol, please call 1-866-WELCHOL.
Sincerely,
Jack Kelly, R.Ph. National Account Manager Trade & Pharmacy Development
August 2002
From Geneva
Given the recent communications received by Geneva voicing concerns regarding the lack of availability of Amoxicillin, Clavulanate Potassium (ACP), Geneva would like to provide you with the following relevant background information.
As you may know, Geneva Pharmaceuticals recently launched ACP, a generic version of GlaxoSmithKline's Augmentin®. Geneva was able to launch at this time as a result of a favorable decision rendered by the Eastern District of Virginia.
While Geneva does no have any legal exclusivity in the marketplace for ACP, we are, as of this date, the only generic manufacturer that has received final approval from the FDA for any of the dosage forms. However, Geneva does expect to have generic competition on ACP form at least two or three manufacturers, thereby satisfying the remaining demand in the marketplace.
Due to the limited availability of ACP, Geneva does not at this time have adequate product to supply ongoing market demands. As such, Geneva's initial distribution of ACP was focused on a limited group of direct buying customers versus a broad allocation of product among all potential customers. It was Geneva's belief that this approach was the most responsible way to launch the ACP product, as any broad allocation to all customers would have provided minimal product to any single customer and would have resulted in significant and continuous supply interruptions, casing a multitude of operational problems for all customers.
It is important to note that FirstDataBank notified Geneva on July 25, 2002 that Augmentin will continue to be coded as single source in the FirstDataBank database for the time being due to limited supply. The classification will not be changed to multi-source until there is an adequate market supply available. FirstDataBank will be communicating this decision to customers under separate cover.
Geneva's supply situation forced us to make difficult choices that, Genova realizes, made an important product unavailable to many of our customers. This situation is also unacceptable to Geneva and we are actively trying to increase the supply of ACP to the United States. Geneva asks for your continued patience and will keep you apprised of product availability as it evolves.
Thank You.
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FROM: WYETH May 28, 2003 Data from the Women's Health Initiative Memory Study (WHIMS), a substudy of the Women's Health Initiative (WHI) conducted in women age 65 and older, have been published in the May 28, 2003, issue of the Journal of the American Medical Association (JAMA). These reports have added to our knowledge concerning the effects og postmenopausal estrogen plus progestin therapy in demantia and cognition. A third article published in the same issue of JAMA updates the WHI stroke data already published in July 2002. Because the findings from the stroke paper are consistant withthose already published and described in product labeling, the focus if this letter is to update you on WHIMS results. WHIMS RESULTS WHIMS, a substudy of WHI supported by Wyeth, was a randomized, placebo-controlled trail that evaluated whether postmenopausal estrogen and progestin hormorne therapy would reduce the risk of dementia in women age 65 and older. WHIMS followed 4,532 women for an average of 4.1 years. The auhors of the WHIMS publication state that women taking combination strogen plus progestin therapy has an increased relative risk (2.05, 95% CI 1.21-3.48) of developing probable demantia (PD) compared to women taking placebo. In both groups, the absolute risk for developing PD was low (45 cases/10,000 women per year for women taking the active drug, 22 cases/10,000 women per year for women taking placebo.) The increase in the relative risk was observed in all age groups studied, began in the second year, and persisted. The absolute risk was highest in the oldest age group studied (women 75 and older). In a seperate report in WHIMS, the effect of hormone therapy on global cognitive function was evaluated. Overall, there was no clinically significant difference between the groups. The average cognitive test score for these women impoved in both the active drug groups and the control group. However, the treated group improved somewhat less than the control group. An independant study arm of WHIMS evaluating the effect of estrogen alone on probable demantia and cognitive function in a similar population is continuing. PRESCRIBING CONSIDERATIONS Wyeth recognizes the potential relevance of this information to all women, paticularily for those age 65 and older. WHIMS evaluated women who were on average 71 years of age, and, therefore, the applicability of these results to younger women is unclear. Even so, the company believes that the WHIMS results should be considered part of the individual assessment or risk and benefit for women who are taking or considering initiating estrogen plus progestin therapy. Wyeht continues to support the appropraite use of hormone therapy for its labeled indications - releif of menopausal symptoms such as hot flashes, night sweats, and vaginal dryness and the concomitant prevention of postmenopausal osteoporosis. Hormone therapy should be prescribed at the lowest dose for the shortest duration consistant with individual treatment goals and risks for the individual woman. LABELING CHANGE Wyeth has updated the warnings and adverse events sections of product labeling for its hormone therapy products to include the following: WARNING Dementia. In a study of women 65 years of age and older (a randomized controlled sub-study of the Women's Health Initiative, the Women's Health Initiative Memory Study: n=4,532, 54% older than 70), those treated with PREMPOR (0.625 mg, conjugated equine estrogen, plus 2.5 mg medroxyprogesterone acetate) were reported to have a two-fold increase in the risk of developing probable dementia. After an average follow-up of 4 years, the absolute risk of probable dementia was 45 per 10,000 women-years in the PREMPRO group and 22 per 10,000 women-years in the placebo group. It is unknown whether these findings apply to younger postmenopausal women. The estrogen-alone sub-study of the Women;s Health Initiative Memory Study is currently ongoing. No data are available. It is unknown whether these findings apply to estrogen alone therapy.
Adverse
Reactions - CNS PREMPRO™ (conjugated estrogens/medroxyprogesterone acetate tablets) is indicated in women witha uterus for the treatment of moderate to severe vasomotor symptoms associated with the menopause, the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause, and the prevention of postmenopaulas osteoporosis. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis after non-estrogen medications have been carefully considered.
WARNING The Women's Health Initiative (WHI) reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with conjugated equine estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative placebo (see CLINICAL PHARMACOLOGY, Clinical Studies section in the full Prescribing Information). Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations of estrogens and progestins were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest efective doses and for the shortest duration consistant with treatment goals and risks for the individual women. The most commonly reported side effects of PREMPRO are metrorrhagis, alopecia, and mastalgia. PREMPRO should not be used under any of the following conditions or circumstances: undiagnosed abnormal genital bleeding; known, suspected, or a history of breast cancer; known or suspected estrogen-dependant neoplasia; active venous thromboembolism; liver dysfunction or disease; in patients with a known hypersensitivity to its ingerdients; known or suspected pregnancy. Please see accompanying Prescribing Information If you have any questions about this information, please contact our Global Medicsl Communications group at 1-800-934-5556.
Sincerely,
Victoria
Kusiak, M.D. |
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FROM: COLUMBIA LABORATORIES, INC. March 2003 Important women's health care products...now available for pharmacies Columbia Laboratories, Inc. develops and commercializes a wide range of innovative prescription (Rx) and over-the-counter (OTC) products, meeting the health care needs of people around the world. With a newly created sales force and increased promotional efforts, Columbia Laboratories will be focusing on marketing its key women's health care products. As a result, you can anticipate increased interest from your patients, so now is the time to have your shelves adequately stocked.
PROCHIEVE™
8% (progesterone gel) (Rx only)
The comfortable and convenient option women prefer
The most common side effects of PROCHIEVE™ 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. PROCHIEVE™ 8% is contraindicated in patients with current or past thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction, or disease, and known or suspected malignancy of the breast or genital organs. Contraindications should be reviewed with patients before prescribing. Please see enclosed full prescribing information.
REFRESH
VAGINAL GEL™ (OTC)
ADVANTAGE-S®
Bioadhesive Contraceptive Gel (OTC)
As an added convenience, Columbia Laboratories is introducing a pharmacy stocking program at the local level. For additional information, please contact our customer service department at 973-994-3999.
Sincerely, |
May 2nd, 2006
Official complaint of Unfair Business Practices and Severe Client Confidentiality violations by Meerdink & Associates and Russell Meerdink himself filed to the Greenville Market Condo Association by RxLink Pharmacy. These unfair business practices are now being reported to State and Federal agencies for proper review. For more information, please contact the Town of Greenville, Wisconsin.
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