U.S. Federal Court Finds in Favor of Allergan, Inc. and Issues Permanent Injunction against Merz Pharmaceuticals and Merz Aesthetics
-- Allergan Also Receives Favorable Rulings Against Merz in
The court concluded that the injunction, which prohibits
In addition to the U.S. ruling,
The findings in
"We believe that full and fair competition is healthy," said David E.I. Pyott, Allergan's Chairman of the Board, President and Chief Executive Officer. "It is important to ensure that physicians and consumers receive accurate and truthful information and are able to make informed decisions about the products they choose to use. As the leader and innovator in the medical aesthetics category, we remain committed to supporting and growing this market on behalf of physicians and the customers they serve."
About BOTOX® (onabotulinumtoxinA)
BOTOX® is a prescription-only medical product that contains
tiny amounts of highly purified botulinum toxin protein refined from the
bacterium, Clostridium botulinum. BOTOX® has a unique,
protected molecular structure that stabilizes the core toxin in BOTOX®
from degradation. When injected at
BOTOX® was first approved by the
In addition to its therapeutic uses, the same formulation of BOTOX®
with dosing specific to moderate to severe glabellar lines was approved
In addition to approximately 21 years of clinical experience, the safety and efficacy of BOTOX® have been well-established in approximately 65 randomized, placebo-controlled clinical trials and in approximately 15,000 patients treated with BOTOX® and BOTOX® Cosmetic in Allergan's clinical trials.1 Worldwide, approximately 30 million vials of BOTOX® and BOTOX® Cosmetic have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1990-2010).2 With approximately 2,500 articles on BOTOX® and BOTOX® Cosmetic in scientific and medical journals,3 BOTOX® neurotoxin is one of the most widely researched medicines in the world.
BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic Important Information
BOTOX® is a prescription medicine that is injected into muscles and used:
- to treat leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease who still have leakage or experience too many side effects after trying an anticholinergic medication.
- to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
- to treat increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spasticity
- to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
- to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective to treat increased stiffness in upper-limb muscles other than those in the elbow, wrist, and fingers, or to treat increased stiffness in lower-limb muscles. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective for severe sweating anywhere other than your armpits.
IMPORTANT SAFETY INFORMATION
BOTOX® and BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® or BOTOX® Cosmetic:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, urinary incontinence in adults with overactive bladder due to neurologic disease, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.
Do not take BOTOX® or BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® or BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Do not take BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.
The dose of BOTOX® and BOTOX® Cosmetic is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. These include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you experience any such symptoms; further injection of BOTOX® or BOTOX® Cosmetic should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® or BOTOX® Cosmetic.
Tell your doctor if you have any breathing-related problems. Your doctor will want to monitor you for any breathing problems during your treatment with BOTOX® for upper limb spasticity.
Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.
Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX®.
Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX® for their upper limb spasticity. Upper respiratory infections (common colds) were also reported more frequently in people with prior breathing-related problems.
Human albumin and spread of viral diseases. BOTOX® and BOTOX® Cosmetic contain albumin, a protein component of human blood. The potential risk of spreading viral diseases (eg, Creutzfeldt-Jakob disease [CJD]) via human serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human serum albumin.
Tell your doctor about all your medical conditions, including if you have: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; pain or burning with urination, frequent urination, fever, have problems emptying your bladder on your own and are being treated for urinary incontinence, are pregnant or plan to become pregnant (it is not known if BOTOX® or BOTOX® Cosmetic can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® or BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® or BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® or BOTOX® Cosmetic in the past.
Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine.
Other side effects of BOTOX® and BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs
Important JUVÉDERM® Safety Information
JUVÉDERM® injectable gel (including JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC, and JUVÉDERM® Ultra Plus XC) is indicated for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Treatment side effects are usually mild to moderate, lasting 7 days or less, and include temporary injection-site reactions such as redness, pain, firmness, swelling, and bumps. JUVÉDERM® is not for people with severe allergies. For more information, please click on the About Safety link at www.juvederm.com or call the Allergan Product Support line at 1-877-345-5372. JUVÉDERM® injectable gel is available by prescription only.
This press release contains "forward-looking statements," including the
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
Myobloc® is a registered trademark of
Dysport® is a registered trademark of
Xeomin® is a registered trademark of
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