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From Dura Pharmaceuticals

Dura announces the availability of cephalosporin 7 day course of treatment in a blister pak.

New Product Announcement! Ceclor CD 500 mg (cefaclor exted release tablets). CD pak.

Dura is pleased to announce the availability of the only cephalosporin with a 7-day BID course of therapy in a blister pak (fourteen 500 mg tablets). CD pak was available for shipping to your wholesaler on December 20, 1999.

Place your pharmacy order for CDpak through your wholesale and receiver a 10% retail stocking incentive (through January 28th, 2000). This 10% retail stocking incentive is made available to retail pharmacy and is passed on to you through your local wholesaler. Product Description: CDpak (cefaclor extended release tablets). NDC: 5147-035-03. Package Size: 3 paks of 14 tablets each. AWP Unite Price: $174.83.

The most commonly reported adverse events in North American clinical trials (N=100) were headache (4.9%), rhinitis (3.9%), diarrhea (3.8%), vaginitis (2.4%), vaginal moniliasis (2.2%), and abdominal pain (1.6%).

Ceclor CD is indicated for acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (non B lactamase producing strains only), Maraxella catarrhalis (including B lactamase-producting strains), or Streptococcus pneumoniae. For further information please contact Dura.

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Abbott Laboratories discontinuing Placidyl (ethcholorvynol capsules, USP, Abbott).

Abbott Laboratories sent a notification letter to prescribers of Placidyl on September 8, 1999 that Placidyl (ethchlorvynol capsules, USP, Abbott) would be discontinued. A follow-up notification letter was sent on December 6, 1999.

Placidyl is indicated as short-term hypnotic therapy for periods up to one week in duration for the management of insomnia.

In December, Abbott had an inventory of 200 mg, 500 mg, and 750 mg Placidyl capsules which they anticipated would last into January 2000, assuming no change in usage. The product may continue to be dispensed until the expiration date on the bottle.

If you have any questions, please call Abbott Laboratories at 800-633-9110. Patients should be encouraged to contact their physicians regarding this situation.

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Mead Johnson to discontinue Enfamil Natalins RxNDC# 0087-070249

December 9, 1999

We want to make you aware of a decision that we have made todiscontinue Enfamil Natalins Rx. our presciption prenatal vitamin supplement.

As you are probably aware, we have been facing increased competition from generic products in this category for several years. The unique Comfort Core technology prevented us from matching the lower prices of the generic products, and also created several challenges in the production of Enfamil Natalins Rx. These challenges have too frequently made it difficult for us to maintain the high standards you expect from us, and we demand of ourselves, in the areas of product supply and order fulfillment.

Health Care Professionals are being notified of this decision, and should discontinue writing new scrips for Enfamil Natalins Rx immediately. In the meantime, you should continue to stock any remaining inventories to meet refill needs of Enfamil Natalins Rx users during this transition period.

We first introduced Natalins in 1952 so this has been a very difficult decision for us. We appreciate your understanding and welcome your comments.

Should you have any questions, please contact us at 1-800-426-7876 (select option 7).

 

Sandy MacPherson

Senior Vice President and General Manager

Mead Johnson Nutritionals


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IMMEDIATE ATTENTION REQUIRED  DISPENSING ERROR ALERT

From: UCB Pharma, Inc.

September 25, 2003

Medication dispensing errors are a serious threat to healthcare and necessitate the combines efforts of all involved to minimize their occurrence.  UBC Pharma, Inc. would like to advise you to that errors may occur between KEPPRA (levetiracetam) tablets and oral solution and KALETRA (lopinavir/ritonavir) capsules and oral solution.  No one is in a better position to help ensure that all patients receive the right treatment than pharmacists.  Patients erroneously receiving either medication would be unnecessarily subjected to to the risk of adverse effects.  In addition, patients with epilepsy who do not receive their antiepileptic drug due to a dispensing error would be inadequately treated and could experience serious consequences, including status epilepticus.

KEPPRA, an antiepileptic, is available as capsules or oral solution.  KEPPRA tablets, 250mg are blue, 500mg are yellow, and 750mg are orange, oblong-shaped, scored, film-coated tablets debossed with "ucb" and "strength" on one side. They are supplied in containers of 120 tablets.  KEPPRA oral solution is a clear, colorless, grape-flavored liquid supplied in 16 fl oz white HDPE bottles containing 500mg levtriacetam per 5ml.

KALETRA, an antiretroviral, is available as capsules or oral solution.  KALETRA 113.3mg lopinavir/33.3mg ritonavir capsules are orange soft gelatin capsules imprinted with the Abbot corporate logo and "PK"KALETRA is available in bottles of 180 capsules. KALETRA oral solution is a light yellow to orange colored liquid supplied in amber-colored glass bottles containing 400mg lopinavir/100mg ritonavir per 5mL.

Please be alert when receiving written and oral prescriptions for KEPPRA and share this letter with your pharmacy staff.  TO decrease the potential for dispensing errors, please continue to employ at least two independent checks in the dispensing process and consider opening the prescription bottle in front of the patient to confirm expected appearance while reviewing the indication. Please also provide the patient leaflet packaged with the product.

If you become aware of a prescription dispensing error involving KEPPRA, please contact UCB Pharma, Inc. immediately at 1-800-477-7877, option 9; the USP Medication Errors Reporting Program at 1-800-233-7767 or the FDA MEDWATCH program by telephone at 1-800-FDA-1088, by FAX at 1-800-FDA-0178, or by the Internet http://www.fda.gov/medwatch.

Thank you for your continued support in this very important matter.

Leslie Magnus, MD     Vice President, Medical Affairs   UCB Pharma, Inc.

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