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FDA APPROVES THE ALLERGY TREATMENT ZYRTEC® FOR USE WITHOUT A
ZYRTEC® and ZYRTEC-D® 12 HOUR® to be Available in Stores Nationwide January 2008
Ft. Washington, PA, November 16, 2007 – McNeil Consumer Healthcare, a division of McNEIL-PPC, Inc., announced today that it received approval from the U.S. Food and Drug Administration (FDA) for the allergy treatment ZYRTEC® (cetirizine HCl) to be used without a prescription for adults and children. ZYRTEC® relieves symptoms due to perennial and seasonal allergic rhinitis, commonly referred to as indoor and outdoor upper respiratory allergies. ZYRTEC® also relieves itching due to hives.
The ZYRTEC® approval comes one week after the FDA granted the company approval to market ZYRTEC-D® 12 HOUR® (cetirizine HCl 5 mg/pseudoephedrine HCl 120 mg), which combines ZYRTEC® with a decongestant. ZYRTEC-D® and ZYRTEC®, the number one prescribed allergy medication in the U.S.*, will be available in stores nationwide** in late January 2008 without a prescription in its original-prescription strength.
“For a decade, ZYRTEC®, as a prescription medication, has been alleviating people’s symptoms from perennial and seasonal allergies,” said Ashley McEvoy, President, McNeil Consumer Healthcare. “By providing ZYRTEC® over-the-counter, we’re offering allergy sufferers greater access to a convenient, effective and affordable treatment option that helps alleviate their specific allergy symptoms. In fact, for many allergy sufferers, ZYRTEC® will cost up to one third less than prescription ZYRTEC®.”
*Based on IMS total prescriptions from 2004-2007** In most states
ZYRTEC® is a once-a-day medication for adults and children that relieves indoor and outdoor allergy symptoms of sneezing, runny nose, and watery eyes for 24 hours. ZYRTEC-D® 12 HOUR® provides the added benefit of relieving nasal congestion. The FDA approved ZYRTEC® in 5mg and 10mg tablets,5mg and 10mg chewable tablets, and 1mg/mL syrup. ZYRTEC-D® 12 HOUR® is also approved as an extended release tablet. ZYRTEC® also relieves itching due to hives.
“As a pharmacist, I often help my customers choose the appropriate medication to treat their indoor and outdoor allergies,” said AnilDatwani, Phar. D., AR-EX Pharmacy, Fords, New Jersey. “The availability of over-the-counter ZYRTEC® is good news for the millions of Americans who suffer from indoor and outdoor allergies and are looking for an easier way to obtain an effective allergy treatment. Now allergy sufferers can go to any convenient location where over-the-counter medications are sold to buy ZYRTEC®, instead of having to visit their allergist or other healthcare provider.”
ZYRTEC® is an antihistamine that helps block the action of histamine to help relieve symptoms caused by allergy triggers such as dust, mold and pet dander, tree pollen, weeds and grasses. ZYRTEC® has proven to be generally well-tolerated. In studies, ZYRTEC® began working within one hour and showed continued symptom relief for a full-24 hours from a single dose. The most common side effects included drowsiness, tiredness, and dry mouth. For more information about ZYRTEC® visit www.ZyrtecOTC.com. Healthcare Professionals can visit www.ZyrtecProfessional.com.
“I’ve suffered from allergies for many years, and have relied on my doctor for a prescription to relieve my worst symptoms,” said allergy patient, Jill Attas. “I tried other medicines, but ZYRTEC® is the only one that truly helped both my indoor and outdoor allergies. It’s great news that ZYRTEC® will be available in local stores in January so I can easily get the medicine I need.”
Millions of Americans suffer from allergies, including indoor and outdoor. Allergies are caused when a person’s body overreacts to
normally harmless substances. These substances are often referred to as triggers. People can experience allergy triggers anytime
throughout the year that can lead to both indoor and outdoor allergies. Indoor allergies can occur year round and are triggered by
substances such as mold, dust, and pet dander. These allergens are often inhaled through the nose and mouth, putting the allergens
in contact with the immune cells in the lining of the nose, mouth, throat, and airways of the lungs causing an allergic response.
Similarly, outdoor allergies can occur when outdoor allergens such as pollens from grasses, weeds and trees are inhaled through the
nose and mouth into the lungs causing an allergic response. Those who suffer from outdoor allergies are often affected by allergies in the spring and fall.
Symptoms for both indoor and outdoor allergies can include itchy, watery eyes, itchy nose, or throat, sneezing and runny nose.
About McNeil Consumer Healthcare
McNeil Consumer Healthcare Division of McNeil-PPC, Inc., a subsidiary of Johnson & Johnson, markets a broad range of well-known
and trusted over-the-counter (OTC) products. McNeil Consumer Healthcare is most widely recognized for the complete line of
TYLENOL® acetaminophen products, the leading pain reliever brand in the adult and pediatric categories. The TYLENOL® product
line consists of hundreds of products across a variety of pain categories including: arthritis pain, pain with accompanying
sleeplessness and upper respiratory. Other McNeil Consumer Healthcare brands include BENADRYL® allergy medicines;
IMODIUM® A-D anti-diarrheal; MOTRIN® IB; PediaCare® upper respiratory medicines for children; ROLAIDS® antacid products; ST.
JOSEPH® Adult Regimen Aspirin; and SUDAFED® and SUDAFED PE® nasal decongestants.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Johnson & Johnson Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events ordevelopments.
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