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|December 19, 2014 8:00 a.m.|
|Teva Announces FDA Approval of QNASL® (Beclomethasone Dipropionate) Nasal Aerosol for Treatment of Children with Seasonal and Perennial Allergic Rhinitis|
First Waterless Nasal Allergy Spray Approved for Children as Young as Four Years of Age
QNASL® 40 mcg is a lower dose formulation of QNASL®
Nasal Aerosol (80 mcg), a waterless (non-aqueous) intranasal
corticosteroid (INS) spray currently available by prescription for
adults and adolescents (12 years of age and older) for the treatment of
nasal symptoms associated with AR. QNASL® 40 mcg delivers
effective symptom relief at one-fourth of the dosage approved to treat
adults and is the first and only waterless hydrofluoroalkane (HFA) nasal
allergy treatment to be approved for use in patients as young as four
years of age. The drug is expected to become available by prescription
“The approval of QNASL® for use in children aged 4-11 is an
important advancement for an often difficult-to-treat patient group,”
“The approval of this lower dose formulation of QNASL® for
children reaffirms Teva’s deep-rooted commitment to developing treatment
options to help address respiratory conditions among all patient
Important Safety Information
Thrush (Candida), a fungal infection in your nose, mouth, or throat may occur. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
You should avoid using QNASL Nasal Aerosol until your nose is healed if you have a sore in your nose, you have had recent surgery on your nose, or if your nose has been injured, because QNASL Nasal Aerosol may cause slow wound healing.
Some people who use corticosteroids may have eye problems such as increased pressure in the eye (glaucoma) or cataracts. If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use QNASL Nasal Aerosol.
Serious allergic reactions can happen in people taking QNASL Nasal Aerosol. Stop using QNASL Nasal Aerosol and call your healthcare provider right away or get emergency help if you experience shortness of breath or trouble breathing, skin rash, redness, swelling, severe itching, or swelling of your lips, tongue or face.
People are more likely to get infections if they have immune system problems or use drugs, including corticosteroids, which may weaken the body’s ability to fight infections. Avoid contact with people who have infections like chickenpox or measles while using QNASL Nasal Aerosol. Speak to your healthcare provider before using QNASL Nasal Aerosol if you have tuberculosis or untreated fungal, bacterial, or viral infections, or eye infections caused by herpes. Symptoms of an infection include: fever, pain, aches, chills, feeling tired, nausea and vomiting.
A condition in which the adrenal glands do not make enough steroid hormones may occur. Symptoms can include tiredness, weakness, dizziness, nausea and vomiting. Tell your healthcare provider if you experience these symptoms.
Children taking QNASL Nasal Aerosol should have their growth checked regularly, since corticosteroids may slow growth in children.
The most common side effects with QNASL Nasal Aerosol 80 mcg in patients 12 years of age and older are nasal discomfort, nosebleeds, and headache.
The most common side effects with QNASL Nasal Aerosol 40 mcg in patients 4 to 11 years of age are headache, fever, infection of the nose and throat, and inflammation of the nose and throat.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of QNASL Nasal Aerosol. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs
About Allergic Rhinitis
According to the
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our innovative products, especially COPAXONE®
(including competition from orally-administered alternatives, as well
as from potential purported generic equivalents); the possibility of
material fines, penalties and other sanctions and other adverse
consequences arising out of our ongoing FCPA investigations and related
matters; our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent and
during the timeframe intended by our cost reduction program; our ability
to identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.