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CAREMARK
October 2007
Volume 3, Issue Number 10
Pipeline Highlights from August 31, 2007 – September 27, 2007 and Recent Selected Healthcare News Highlights
A monthly publication highlighting recent events in the pharmaceutical industry
Pipeline
Upcoming First Generic and Rx-to-OTC Product Approvals/Launches1
Please note: The information below is subject to change and is represented to the best of our knowledge at the time of this publication.
cetirizine
(Zyrtec®)
Anticipated Potential Generic
Dosage Form; Strength(s)
Tablet(s); 5 mg
Tablet(s), chewable; 5 mg and 10 mg
Syrup; 5 mg/5 mL
Anticipated Potential OTC
Dosage Form; Strength(s)
Tablet(s); 10 mg
Anticipated Launch Date†
Generic forms of Zyrtec 5 mg/ 5 mL syrup, 5 mg tablets, and 5 mg and 10 mg chewable tablets are expected to be
available in December of this year for the treatment of seasonal allergic rhinitis in adults and children two years of age or
older, and the treatment of perennial allergic rhinitis and chronic urticaria in adults and children six months of age or older.
Zyrtec 10 mg tablets are expected to be available OTC in January 2008 for the management of seasonal and perennial
allergic rhinitis.
cetirizine/
pseudoephedrine
(Zyrtec-D 12 hour®)
Comments
The reference brand is used in the treatment of seasonal allergic rhinitis in adults and children two years of age or older, and
the treatment of perennial allergic rhinitis and chronic urticaria in adults and children six months of age or older. Zyrtec
and Zyrtec-D may or may not continue to be available as brand-name products upon availability of the OTC products.
Anticipated Potential OTC
Dosage Form; Strength(s)
Tablet(s); 5 mg/120 mg
Anticipated Launch Date†
Zyrtec-D is expected to be available OTC in January 2008.
Comments
The reference brand is used in the relief of nasal and non-nasal symptoms of seasonal and perennial allergic rhinitis in
adults and children 12 years of age and older. Zyrtec and Zyrtec-D may or may not continue to be available as
brand-name products upon availability of the OTC products.
First Generic Product Approvals/Launches2,3*
albuterol
(Accuneb®)
Dosage Form; Strength(s)
Solution, inhalation; 0.75 mg/3 mL and 1.25 mg/3 mL
Approval Date‡
September 25, 2007
Launch Date†
September 27, 2007
Comments
The reference brand is used in the relief of bronchospasm in children with asthma who are 2 years to 12 years of age.
This product is AB-rated.
carvedilol
(Coreg®)
Dosage Form; Strength(s)
Tablet(s); 3.125 mg, 6.25 mg, 12.5 mg and 25 mg
Approval Date‡
September 5, 2007
Launch Date†
September 5, 2007
Comments
The reference brand is used in the treatment of mild-to-severe chronic heart failure, left ventricular dysfunction following
myocardial infarction in clinically stable patients, and hypertension.
This product is AB-rated and is available as a multi-source generic product.
famciclovir
(Famvir®)
Dosage Form; Strength(s)
Tablet(s); 125 mg, 250 mg and 500 mg
Approval Date‡
August 24, 2007
Launch Date†
September 5, 2007
Comments
The reference brand is used in the treatment or suppression of recurrent genital herpes or treatment of recurrent cold
sores in patients with healthy immune systems; treatment of shingles; or treatment of herpes simplex infections in
HIV-infected patients.
This product is AB-rated and was launched as a single-source generic product. Teva has been allowed to return this
product to market, however, there may still be some issues with availability.
OTC=over-the-counter; HIV= human immunodeficiency virus
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Recent Product Launches2,3*
Selzentry™
(maraviroc)
Dosage Form; Strength(s)
Tablet(s); 150 mg and 300 mg
Indication(s)
Combination antiretroviral treatment of adults infected only with CCR5-tropic HIV-1 detectable, who have evidence of
viral replication and who have HIV-1 strains resistant to multiple antiretroviral agents
Launch Date†
September 10, 2007
Comments
This product will be available via Caremark Specialty Pharmacy Services upon launch.
Pfizer Inc
CCR5=chemokine receptor 5, HIV=human immunodeficiency virus
Recent New Drug Application (NDA) Approvals2,3*
Dosage Form, Strength(s)
Injection, subcutaneous; 60 mg, 90 mg and 120 mg
Indication(s)
Ipsen Pharma
Biotech/
Long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy,
or for whom surgery and/or radiotherapy is not an option
Approval Date
August 30, 2007
Tercica Inc.
Anticipated Launch Date†
Fourth Quarter 2007
Comments
This product will be available via Caremark Specialty Pharmacy Services upon launch.
Somatuline®
Depot (lanreotide)
Recent Supplemental New Drug Application (sNDA) Approvals2,3*
Evista®
(raloxifene)
Dosage Form
Tablet(s)
Indication(s)
Reduction of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high
risk for invasive breast cancer
Approval Date
September 13, 2007
Comments
This is a new indication for an already-approved product.
Dosage Form, Strength
Tablet(s) and Injection, intravenous; 750 mg
Indication(s)
Treatment of adults with mild, moderate and severe complicated urinary tract infection and acute pyelonephritis, in a
short course of therapy
Approval Date
September 14, 2007
Comments
This is a new indication for an already-approved product.
Plavix
(clopidogrel)
Dosage Form, Strength
Tablet(s); 300mg
Indication(s)
Loading dose for appropriate acute coronary syndrome (ACS) patients as soon as possible after hospital admission
sanofi-aventis
U.S. LLC
Approval Date
September 27, 2007
Comments
This is a new strength for an already-approved product. The 300-mg tablet is expected to be available later this year.
Eli Lilly &
Company
Levaquin®
(levofloxacin)
Ortho-McNeil
Pharmaceutical,
Inc.
®
Recent Supplemental Biologic License Application (sBLA) Approvals2,3*
Norditropin®
(somatropin
[rDNA origin])
Dosage Form
Injection, subcutaneous
Indication(s)
Treatment of children with short stature associated with Turner syndrome
Approval Date
September 21, 2007
Novo Nordisk
Comments
This is a new indication for an already-approved product.
This product will be available via Caremark Specialty Pharmacy Services upon launch.
* Adapted from RxPipeline Services Week In Review. For more information contact: [email protected]<mailto:[email protected]>
† This Launch Date/Anticipated Launch Date may not reflect the date of availability for this medication. Due to circumstances beyond the control of Caremark, information related to prospective medication launch dates is subject to
change without notice. This information should not be solely relied upon for decision-making purposes.
‡ The Approval Date is established by the FDA, but does not necessarily mean a generic product is available as of that date, or that such product is available.
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News
Medication Safety
Information regarding select medication safety issues can be found on the Caremark Web site at www.caremark.com > For Health Professionals > Drug Safety Alerts.
Fentora™ (fentanyl) Safety Concerns4
On September 26, 2007, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals and patients to concerns regarding
the use of Fentora (Cephalon Inc.) tablets after recent reports of deaths and other adverse events. The deaths reported were the result of
improper selection of patients, dosing or product substitution.
•
The FDA warned physicians and other healthcare professionals that it is critical to follow product labeling when administering Fentora. It
is dangerous to use Fentora for any short-term pain such as headaches or migraines and it is critical that Fentora not be used in patients
who are not opioid-tolerant.
•
In addition, the FDA is concerned about the improper substitution of Fentora, a quick-acting pain medication, for other pain mediations.
•
Fentora is not the same as other fentanyl products and cannot be substituted for Actiq® (oral transmucosal fentanyl, Cephalon Inc.),
another fentanyl product used to treat breakthrough cancer pain. Because Fentora delivers more fentanyl to the blood than Actiq, substituting
Fentora for Actiq, using the same dose, can result in a fatal overdose.
•
Caremark has standard prior authorization criteria available for oral fentanyl products (Fentora and Actiq). If you are interested in learning
more about utilization management for these medications, please contact your Caremark account representative.
This medication safety issue has been reviewed by the Caremark Drug Safety Alert (DSA) program.
New Guidance for Use of Viracept® (nelfinavir) in Pregnant Women and Pediatric Patients5
On September 10, 2007, Pfizer Inc informed healthcare professionals of the presence of ethyl
methanesulfonate (EMS), a process-related impurity, in Viracept and provided guidance regarding
the use of Viracept in pregnant women and pediatric patients.
•
EMS is a potential human carcinogen. Data from animal studies indicate EMS is teratogenic,
mutagenic and carcinogenic; however, no data from humans exist.
•
The FDA asked Pfizer to implement new specifications to limit the presence of EMS in Pfizermanufactured Viracept products marketed in the United States.
•
For pediatric patients who are stable on Viracept-containing regimens, the FDA and Pfizer agree
that the benefit-risk ratio remains favorable and those patients may continue to receive Viracept.
Pediatric patients who need to begin human immunodeficiency virus (HIV) treatment should not
start regimens containing Viracept until further notice.
•
Pregnant women who need to begin antiretroviral therapy should not be offered regimens containing Viracept until further notice. As a
precautionary measure, pregnant women currently receiving Viracept should be switched to an alternative antiretroviral therapy while
Pfizer and the FDA work to implement the long term EMS specification for Viracept.
•
For pregnant women with no alternative treatment options, the FDA and Pfizer agree that the risk-benefit ratio remains favorable for the
continued use of Viracept.
This medication safety issue has been reviewed by the Caremark DSA program. Caremark is prepared to answer inquiries from participants
and has sent an iScribe® notification to physicians.
continued on Page 4
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Voluntary Market Withdrawal of Daytrana™ (methylphenidate) Patches6
On September 4, 2007, Shire plc announced the voluntary market withdrawal of a limited amount of Daytrana (Shire US Inc) patches, which
are used in the treatment of attention deficit and hyperactivity disorder (ADHD).
•
Only Daytrana packages with an expiration date of March 31, 2009 or earlier and Daytrana packages with lot numbers 2563511, 2563611
and 2570411 are impacted by this voluntary market withdrawal.
•
The manufacturer is taking this proactive step not due to safety and efficacy issues, but due to feedback from patients and caregivers
who have experienced difficulty removing the release liner from some Daytrana patches.
•
All Daytrana patches, including those that are part of the voluntary market withdrawal, can continue to be used unless the release liner
cannot be removed, or the patches are damaged while being opened. Patients and their caregivers who have questions regarding
Daytrana patches should call Shire Customer Service toll-free at 1-800-828-2088 and select option 1.
This medication safety issue has been reviewed by the Caremark DSA program. Caremark is prepared to answer inquiries from participants
and has sent an iScribe® notification to physicians.
References:
1. Caremark Internal data.
2. Caremark. RxPipeline Insider. Available at: www.rxpipelineinsider.com. Accessed September 7, 2007; September 14, 2007, September 21, 2007 and September 28, 2007.
3. Drugs@FDA. Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed September 27, 2007.
4. FDA MedWatch. Fentora (fentanyl buccal tablet). Food and Drug Administration Web site. http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora. Accessed September 27, 2007.
5. FDA MedWatch. Viracept (nelfinavir mesylate). Food and Drug Administration Web site. http://www.fda.gov/medwatch/safety/2007/safety07.htm#Viracept. Accessed September 25, 2007.
6. Shire voluntarily withdraws a limited portion of Daytrana™ (methylphenidate) transdermal system patches [press release]. Philadelphia, PA: Shire plc.; September 4, 2007. http://www.daytrana.com/PDFs/DaytranaInfo.pdf.
Accessed September 25, 2007.
© Copyright 2007 Caremark. All rights reserved. Any names and trademarks listed herein are the property of their respective manufacturers.
Please note: This document provides a brief overview of various subjects. This letter is provided as reference material and is based in part on information derived from third parties. Caremark does not assume liability or responsibility
for the accuracy or completeness of any third-party material footnoted in this letter. Caremark does not operate the Web sites listed here, nor is it responsible for the availability or reliability of their content.
These listings do not imply or constitute an endorsement, sponsorship or recommendation by Caremark.
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