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IMPORTANT SAFETY INFORMATION From Janssen Pharmaceuticals Products, L.P. and Ortho Biotech Products, L.P. March 22, 2004                       Janssen Pharmaceutica Products, L.P. and Ortho Biotech Products, L.P. would like to inform you of recent labeling changes made for PORANOX (itraconazole) Capsules, SPORANOX (itraconazole) Oral Solution and SPORANOX (itraconazole) Injection.   The revisions to the labeling have been made as a result of the company's ongoing review of the safety data and knowledge of potential cytochrome P450 3A4 drug interactions.  Clinicians are advised to review the pertinent sections of the prescribng information carefully.  Apackage insert for each formalation has beeen enclosed for your review. We wish to draw your attention to the Boxed Warning, Special Populations, Contraindications, Warnings, Drug Interactions, Pregnancy, and Post-marketing experience sections of the revised SPORANOX labeling that includes these important changes. Underline words denote newly added information. THE FOLLOWING CHANGES APPLY TO THE SPORANOX(ITRACONAZOLE) CAPSULES, ORAL SOLUTION, AND INJECTION: BOX WARNING Drug Interactions: Coadministration of  cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl)with SPORANOX (itraconazole) Capsules, injection or Oral Solution is contraindicated.  SPORANOZ, a potent cytochrome P450 3A4 isoenzyme system (CYP3A4) inhibitor, may increase plasma concentrations of drugs metabolized by this pathway.  Serious cardiovascular events, including QT prolongation, torsades depoints, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using cisapride, pimozide, levacetymethadol (levomethadyl). or quinidine, concomitantly with SOPRANOX and/or other CYP3A4 inhibitors.  See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions for more information. CONTRAINDICATIONS Drug Interactions: Concomitant administration of SPORANOX (itraconazole) Capsules, Injection, or Oral Solution and certain drugs metabolized by the cytochrome P450 3A4 isoenzyme system (CYP3A4) may result in increaded plasma concentrations of those drugs, leading to potentially serious and/or life-threatening adverse events.  Cisapride, oral midazolam, pimozide, quinidine, dofetilide, triazolam, and levacetylmethadol (levomethadyl) are contraindicated with SPORANOX. HMG CoA-reductase inhibitors metabolized by CYP3A4, such as lovastatin and simvastatin, are also contraindicated with SPORANOX. Ergot alkaloids metabolized by CYP3A4 such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) and contraindicated withSPORANOX. (See BOX WARNING, and PRECAUTIONS: Drug Interactions.) WARNINGS Cardiac Dysrhythmias:  Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl)  or quinidine concomitantly with SPORANOX and/or other CYP3A4 inhibitors.  Concomitanty administration of these drugs with SPORANOX is contraindicated.  (See BOX WARNING, CONTRAINDICATIONS, and PRECAUTIONS: Drug Interactions. ) DRUG INTERACTIONS The following drugs have been added to Table 1: Selected Drugs that are predicted to alter the plasma concentration of itraconazole or have their plasma concentration altered by SPORANOX: Disopyramide, levacetylmethadol (levomethadyl), ergot alkaloid, halofantrine, budesonide, dexamethasone, cilostazol, eletriptan. This List is not all-inclusive. Excerts from the revised labeling related to these drug interactions are listed below: The class IA antiarrhythmic disopyramide has the potential to increase the QT interval at high plasma concentrations.  Caution is advised when SPORANOX  and disopyramide are administered concomitntly. Levacetylmethadol (levomethadyl) is known to prolong the QT interval and is metabolized by CYP3A4. Co-administration of levacetylmethadol with SPORANOX could result in serious cardiovascular events.  Therefore, concomitant administration of SPORANOX is contraindicated. Elevated concentation of ergot alkaloids can cause ergotism, i.e. a risk for vasospasm potentially leading to cerbral ischemia and/or ischemia of the extremities. Concomitant administration of ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) with SPORANOX contraindicated. Halofantrine has the potential to prolong the QT interval at high plasma concentrations.  Caution is advised when SPORANOX and halofantrine are administered concomitantly. SPORANOX may inhibit the metabolism of certain glococorticosteroids such as budesonide, dexamethasone and methylprednisolone. Colostazol and eletriptan are CYP3A4 metabolized drugs that should be used with caution when co-administered with SPORANOX. Pregnancy: During post-marketing experience, cases of congenital abnormalities have been reported: (See ADVERSE REACTIONS, Post-marketing Experience.) POST-MARKETING EXPERIENCE This section has been revised to include the following adverse events: Anaphylactic, anaphylactoid and allergic reactions, and photosensitivity.  There is limited information on the use of SPORANOX during pregfnancy.  Cased of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience.  A causal relationship wth SPORANOX has not been established. THE FOLLOWING CHANGE APPLIES TO SPORANOX IV: CLINICAL PHARMACOLOGY Special Populations                                                                                                                                      Renal Insufficiency: In patients with mild to moderate renal impairment, SPORANOX IV should be used with caution.  Serum creatinine levels should be closely monitored and, if renal toxicity is suspected, consideration should be given to changing to SPORANOX Capsules. THE FOLLOWING CHANGE APPLIES TO SPORANOX ORAL SOLUTION: WARNINGS Treatment of Severely Neutropenic Patients: SPORANOX Oral Solution as treatment for oropharyngeal and/or esophageal candidiasis was not investigated in severely neutropenic patients.  Due to its pharmacokinetic properties.  SPORANOX Oral Solution is not redommended for initiation of treatment in patients at immediate risk of systemic candidiasis. SPORANOX (itraconazole) Injection and SPORANOX (itraconazole) Oral Solution are distributed by Ortho Biotech Products, L.P. SPORANOX (itraconazole) Capsules are distributed by Janssen Pharmaceutica Products, L.P. Janssen Pharmaceutical and Ortho Biotech are committed to providing you with the most current product information available for the management of your patients receiving SPORANOX.  You can further our understanding of adverse events by reporting all cased to Janssen or Ortho Biotech at the contact numbers listed below or to the FDA MedWatch Program by phone at 1-800-FDA-1088.  The FDA MedWatch Program may also be reached by fax at 1-800-FDA-0178, by mail (using postage-paid form) MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or via www.FDA.gov/medwatch. Please rfefer to the enclosed full Prescribing Information for additional details regarding SPORANOX.  For additional medical information, please call between 9AM to 4:30 PM EST, Monday through Friday. SPORANOX Capsules:                                                                           1-800-JANSSEN (526-7736) SPORANOX Oral Solution or SPORANOX , Injection       Ortho Biothech Medical Information: 1-800-325-7504, Prompt#2 Sincerely, Christine Cote, M.D.     Vice President, Medical Affairs        Janssen Pharmaceutica Products, L.P.   Marc Kamin, M.D.    Vice President, Clinical Affairs     Ortho Biotech Products, L.P.

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From Schering-Plough September 2004 Dear Pharmacist: This letter is to inform you of changes, effective immediately, in how INTRON A (Interferon alfa-2b, recombinant) Powder for Injection is supplied. Please be aware that there is a new diluent with new storage requirements. NEW DILUENT The new diluent supplied with INTRON A Powder for Injection will now be Sterile Water for Injection, USP provided in a 1-ml size only. This replaces the Bacteriostatic Water for Injection, USP previously provided in various size vials. This new diluent does not contain a preservative. After reconstitution and withdrawal of a single dose, the vial and remaining contents must be discarded.                                                                                          Products with New Diluent Vial Strength(Powder)                   New Diluent Size                       Old Diluent Size                        NDC Code (Not Changed) 10 MIU                                          1 mL                                         2mL                                         0085-0571-02 18 MIU                                          1 mL                                         1 mL                                        0085-1110-01 50 MIU                                          1 mL                                          1 mL                                        0085-0539-01 NEW STORAGE REQUIREMENTS Please be aware of and instruct patients on the new storage requirements. After reconstitution, INTRON A Powder for Injection should be used immediately, but may be stored up to 24 hours at 2 degrees to 8 degrees C (36 degrees to 46 degrees F). Storage for INTRON A Powder for Injection before reconstitution remains the same at between 2 degrees and 8 degrees C (36 degrees and 46 degrees F). The change in diluent size does not affect dosing in any way. The vials of INTRON A lyophilized powder have always been and still are single-use vials. Also, the NDC numbers are not affected by these changes; thus, there is no impact on your ability to order the INTRON A powder products. You simply continue to order the INTRON A powder presentations as you have in the past. We are also informing physicians of these changes. You should continue to dispense any existing product you may have in stock containing the Bacteriostatic Water for Injection diluent. Please see enclosed full Prescribing Information. Your Schering sales representative will be happy to discuss with you any questions you may have regarding these changes, or call Schering's customer service at 1-800-222-7579. Sincerely, Bruce Briggs, RPh Director of Pharmacy Development

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12/09/04 From Duramed Subsidiary of Barr Pharmaceuticals, Inc. Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., is pleased to announce the acquisition of Plan B (levonorgestrel) tablets, 0.75 mg- now the only marketed emergency contraceptive. Plan B, currently available by prescription, is a progestin-only pill. Since Preven  (levonorgestrel) 0.25 mg/ethinyl estradiol 0.05 mg tablet USP) has been discontinued and is no longer manufactured, Plan B provides a safe and effective alternative for emergency contraception. If you receive any prescription for Preven, you should contact the prescriber and offer Plan B as the safe and effective alternative. Plan B is not an abortifacient; it is not effective if a women is already pregnant. Plan B can prevent pregnancy in cases of contraceptive failure or unprotected intercourse. For optimal efficacy, a woman must take the first tablet as soon as possible within 72 hours and the second tablet 12 hours later. Plan B can reduce the risk of pregnancy by 89% when taken as directed. Each packet of Plan B contains a single, 2 tablet course of treatment. The NDC number is 51285-038-93. Plan B May be appropriate when a woman -Engaged in intercourse without contraception protection -Used a barrier methods of contraception that failed during intercourse or failed to follow their contraceptive regimen -Was raped Plan B broadens the contraceptive options Duramed offers to women. Our sales force will provide you with materials to support the use of Plan B. Information for professionals and patients is available at www.go2planB.com. Our Plan B information line can be accessed toll free at 1-800-330-1271 from 8AM to 7PM EST. Stocking Plan B is the critical first step. Order Plan B now from your wholesaler or call 1-800-330-1271. We hope you will help Duramed Pharmaceuticals provide access to women in need of emergency contraception. Stocking Plan B is especially important, since timing is critical to the efficacy of Plan B. Very Truly Yours, Ericka Higgins Product Manager PS: Coming soon! Duramed Pharmaceuticals will be conducting a full-scale launch of Plan B, complete with new materials for professionals and patients in the near future. In the interim, our sales representatives will be calling on you with patient materials and literature for professionals. Plan B is contraindicated in women with known or suspected pregnancy, hypersensitivity to any component of the product, or undiagnosed abnormal genital bleeding. Plan B is not recommended for routine use as a contraceptive. Plan B is not effective in terminating an existing pregnancy. Plan B does not protect against HIV infection and other sexually transmitted diseases (STDs). Menstrual bleeding may be heavier or lighter after taking Plan B. If menses are delayed beyond one week, pregnancy should be considered. Severe abdominal pain may signal a tubal (ectopic) pregnancy. Common side effects associated with the use of Plan B include nausea, abdominal pain, fatigue, headache, and menstrual changed.

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