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Recipients of the Prix Galien Awards will be announced at the
“Innovation is a key measure of Allergan’s commitment to R&D,” said
OZURDEX® is a biodegradable steroid implant that uses the proprietary and innovative NOVADUR® solid polymer delivery system to release medicine over an extended period of time. The OZURDEX® implant is approved for three ophthalmic indications in
SERI® Surgical Scaffold is a sterile, silk-derived bioprotein, ultrapurified using the BIOSILK™ process. This unique product is the first and only silk-derived biological scaffold cleared by the
BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected 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.
It is not known whether BOTOX® is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
IMPORTANT SAFETY INFORMATION
BOTOX® 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®:
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.
Do not take BOTOX® if you: are allergic to any of the ingredients in BOTOX® (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.
The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. These reactions 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® should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis (ALS or
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; 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; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® 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®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; take anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).
Other side effects of BOTOX® 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 to the
Please see BOTOX® full Product Information including Boxed Warning and Medication Guide.
OZURDEX® (dexamethasone intravitreal implant) is a prescription medicine that is an implant injected into the eye (vitreous) and used:
IMPORTANT SAFETY INFORMATION
OZURDEX® should not be used if you have any infections or diseases in the eye, or surrounding eye area, including most viral diseases of the cornea and conjunctiva, including active herpes viral infection of the eye, vaccinia, varicella, mycobacterial infections, and fungal diseases.
OZURDEX® should not be used if you have advanced glaucoma.
OZURDEX® should not be used if you have a posterior lens capsule that is not intact.
You should not use OZURDEX® if you are allergic to any of its ingredients.
Injections into the vitreous in the eye, including those with OZURDEX®, are associated with serious eye infection (endophthalmitis), eye inflammation, increased eye pressure, and retinal detachments. Your eye doctor may monitor you regularly after the injection.
Use of corticosteroids may produce posterior subcapsular cataracts, increased eye pressure, glaucoma, and may increase the establishment of secondary eye infections due to bacteria, fungi, or viruses. Let your doctor know if you have a history of ocular herpes simplex.
There may be a risk of the implant moving into the front chamber of the eye if you had the posterior capsule of the lens removed or if you have a tear in the capsule.
The most common side effects reported in patients for retinal vein occlusion and uveitis include: increased eye pressure, conjunctival blood spot, eye pain, eye redness, ocular hypertension, cataract, vitreous detachment, and headache.
The most common side effects reported in patients with diabetic macular edema include: cataract, increased eye pressure, conjunctival blood spot, reduced vision, inflammation of the conjunctiva, specks that float in the field of vision, swelling of the conjunctiva, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, inflammation of the cornea, anterior chamber inflammation, retinal tear, drooping eyelid and high blood pressure.
After repeated injections with OZURDEX®, a cataract may occur. If this occurs, your vision will decrease and you will need an operation to remove the cataract and restore your vision. You may develop increased eye pressure with OZURDEX® that will need to be managed with eye drops and, rarely, with surgery.
In the days following injection with OZURDEX®, you may be at risk for potential complications including in particular, but not limited to, the development of serious eye infection or increased eye pressure. If your eye becomes red, sensitive to light, painful, or develops a change in vision, you should seek immediate care from your eye doctor. You may experience temporary visual blurring after receiving an injection and should not drive or use machinery until your vision has resolved.
Please click here for full Prescribing Information.
FDA Cleared Use
SERI® Surgical Scaffold is used to support and repair weakened soft tissue by adding the extra support needed to achieve the desired surgical result. It is used to reinforce and repair soft tissue during plastic and reconstructive surgery, and during general soft tissue reconstruction.
Important Safety Information
Who should not use SERI® Surgical Scaffold?
SERI® Surgical Scaffold should NOT be used in:
What else is important to know?
What potential issues may result from the use of SERI® Surgical Scaffold?
Issues that may occur are those that can result from a surgically implanted material. These include infection, redness, the attachment of implanted material to tissue surfaces in the body, the creation of an abnormal opening from one tissue surface to another, and when the skin breaks down and the implant appears through the skin.
For more information, please see www.allergan.com or call Allergan Product Support at 1-800-433-8871.
SERI® Surgical Scaffold is available by prescription only.
This press release contains "forward-looking statements," including the statements by
Myobloc® is a registered trademark of
Dysport® is a registered trademark of
Xeomin®is a registered trademark