2. Allergan Programs Policy:
Off-Label Questions
If a physician-speaker is asked an unsolicited question, he/she may
briefly answer that question even if the question involves information
inconsistent with Allergan’s approved product labeling
Physician-speaker must adhere to the Programs Policy when
answering a question involving an off-label use of Allergan products
The physician must:
– Indicate that the information under discussion is not consistent with the
FDA-approved labeling
– Note that the information being exchanged is based on his/her own
professional clinical experience as a physician, and
– If the physician believes, in the exercise of his/her medical and scientific
judgment, that the question should be answered, he/she may briefly
answer the question, but the speaker should then immediately return the
discussion to approved uses of Allergan products
3. The Allergan Medical Family of Products
The first and
only FDA-
approved product
indicated to treat
hypotrichosis of
the eyelashes by
increasing their
growth, including
length, thickness,
and darkness
The first and
only FDA-
approved product
indicated to treat
hypotrichosis of
the eyelashes by
increasing their
growth, including
length, thickness,
and darkness
The first treatment
approved by the
FDA for moderate
to severe glabellar
lines in patients
18 to 65 years of age
The first treatment
approved by the
FDA for moderate
to severe glabellar
lines in patients
18 to 65 years of age
The #1 selling dermal
filler in the US1
with:
Smooth Flow
Smooth Consistency
Provides a smooth,
natural look and feel
Smooth Outcomes
The #1 selling dermal
filler in the US1
with:
Smooth Flow
Smooth Consistency
Provides a smooth,
natural look and feel
Smooth Outcomes
Advances skin
care with GLX
Technology™
to help daily
rejuvenation
Advances skin
care with GLX
Technology™
to help daily
rejuvenation
Facial Aesthetics Portfolio
Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15, JUVEDERM ® Important Safety
Information on slide 16, and LATISSE®
Important Safety Information on slides 39-43.
1. Data on file, Allergan, Inc., November 2009; US Facial Injectables Market
Share Report; GuidePoint Global Filler Share Tracker.
4. Allergan Provides a Complete Array of Products for
Facial Aesthetics
Moderate to
severe glabellar
lines
Chin Wrinkles*
Nasolabial Folds*Perioral Lines*
Marionette Lines*
Hypotrichosis of
the Eyelashes
Skin Care
*When diagnosed as a moderate to severe wrinkle or fold.
Please see BOTOX®
Cosmetic Important
Safety Information
including Boxed
Warning on slides 7-15,
JUVEDERM ®
Important
Safety Information on
slide 16, and LATISSE®
Important Safety
Information on slides
39-43.
6. History of Development, FDA Approvals, and
Clinical Trials
FDA approval for
cervical dystonia
FDA approval
for moderate to
severe glabellar lines
FDA approval
for hyperhidrosis
inadequately managed
with topical agents
BOTOX®
(onabotulinumtoxinA)
20th anniversary
Botulinum Toxin
Type A first isolated
1920s 1978 1989 2000 2002 2004 20091991
FDA = US Food and Drug Administration.
First therapeutic
testing in humans
with Oculinum
Dr. Allen Scott
FDA approval of
Oculinum for
blepharospasm,
strabismus
Allergan changes
product name
to BOTOX®
6
7. Indications
BOTOX®
is indicated for the treatment of cervical dystonia in adults to decrease the
severity of abnormal head position and neck pain associated with cervical dystonia.
BOTOX®
is indicated for the treatment of strabismus and blepharospasm associated with
dystonia, including benign essential blepharospasm or VII nerve disorders in patients
12 years of age and above.
The efficacy of BOTOX®
treatment in deviations over 50 prism diopters, in restrictive
strabismus, in Duane’s syndrome with lateral rectus weakness, and in secondary
strabismus caused by prior surgical over-recession of the antagonist has not been
established. BOTOX®
is ineffective in chronic paralytic strabismus except when used
in conjunction with surgical repair to reduce antagonist contracture.
BOTOX®
is indicated for the treatment of severe primary axillary hyperhidrosis that is
inadequately managed with topical agents.
BOTOX®
Cosmetic is indicated for the temporary improvement in the appearance of
moderate to severe glabellar lines associated with corrugator and/or procerus muscle
activity in patients 18 to 65 years of age.
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
7
8. IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of BOTOX®
or BOTOX®
Cosmetic and all
botulinum toxin products may spread from the area of injection to produce symptoms
consistent with botulinum toxin effects. These may include asthenia, generalized
muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria,
urinary incontinence, and breathing difficulties. These symptoms have been reported
hours to weeks after injection. Swallowing and breathing difficulties can be life
threatening, and there have been reports of death. The risk of symptoms is probably
greatest in children treated for spasticity, but symptoms can also occur in adults
treated for spasticity and other conditions, particularly in those patients who have
underlying conditions that would predispose them to these symptoms. In unapproved
uses, including spasticity in children and adults, and in approved indications, cases of
spread of effect have occurred at doses comparable to those used to treat cervical
dystonia and at lower doses.
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
8
9. CONTRAINDICATIONS
BOTOX®
and BOTOX®
Cosmetic are contraindicated in the presence of infection at the
proposed injection site(s) and in individuals with known hypersensitivity to any
botulinum toxin preparation or to any of the components in the formulation.
WARNINGS
The recommended dosage and frequency of administration for BOTOX®
or
BOTOX®
Cosmetic should not be exceeded. Risks resulting from administration
at higher dosages are not known.
Lack of Interchangeability Between Botulinum Toxin Products
The potency Units of BOTOX®
and BOTOX®
Cosmetic are specific to the preparation and
assay method utilized. They are not interchangeable with other preparations of
botulinum toxin products and, therefore, Units of biological activity of BOTOX®
and
BOTOX®
Cosmetic cannot be compared to or converted into Units of any other
botulinum toxin products assessed with any other specific assay method.
9
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
10. WARNINGS (continued)
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive, serious adverse event reports of distant spread of toxin effect associated
with dermatologic use of BOTOX®
/BOTOX®
Cosmetic at the labeled dose of 20 Units
(for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have
been reported.
No definitive, serious adverse event reports of distant spread of toxin effect associated
with BOTOX®
for blepharospasm at the recommended dose (30 Units and below) or
for strabismus at the labeled doses have been reported.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions
include anaphylaxis, urticaria, soft-tissue edema, and dyspnea. If such reactions
occur, further injection of BOTOX®
or BOTOX®
Cosmetic should be discontinued and
appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has
been reported in which lidocaine was used as the diluent and, consequently, the
causal agent cannot be reliably determined.
10
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
11. WARNINGS (continued)
Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or
neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton
syndrome) should be monitored particularly closely when given botulinum toxin.
Patients with neuromuscular disorders may be at increased risk of clinically significant
effects including severe dysphagia and respiratory compromise from typical doses of
BOTOX®
or BOTOX®
Cosmetic.
11
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
12. PRECAUTIONS
Caution should be used when BOTOX®
or BOTOX®
Cosmetic treatment is used in patients
who have an inflammatory skin problem at the injection site, marked facial asymmetry,
ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or the
inability to substantially lessen glabellar lines by physically spreading them apart.
Information for Patients
Patients should be counseled that if loss of strength, muscle weakness, or impaired
vision occur, they should avoid driving a car or engaging in other potentially
hazardous activities.
Pregnancy
Administration of BOTOX®
or BOTOX®
Cosmetic is not recommended during
pregnancy. There are no adequate and well-controlled studies of BOTOX®
or
BOTOX®
Cosmetic in pregnant women.
Nursing Mothers
It is not known whether BOTOX®
or BOTOX®
Cosmetic are excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when
BOTOX®
or BOTOX®
Cosmetic are administered to a nursing woman.
12
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
13. ADVERSE REACTIONS
General
The most serious adverse events reported after treatment with botulinum toxin include
spontaneous reports of death, sometimes associated with anaphylaxis, dysphagia,
pneumonia, and/or other significant debility.
There have also been reports of adverse events involving the cardiovascular system,
including arrhythmia and myocardial infarction, some with fatal outcomes. Some of
these patients had risk factors including pre-existing cardiovascular disease.
Cervical Dystonia
The most frequently reported adverse reactions following injection of BOTOX®
for cervical
dystonia include dysphagia (19%), upper respiratory infection (12%), neck pain
(11%), and headache (11%).
13
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
14. ADVERSE REACTIONS (continued)
Blepharospasm
The most frequently reported treatment-related adverse reactions following injection of
BOTOX®
for blepharospasm include ptosis (20.8%), superficial punctate keratitis
(6.3%), and eye dryness (6.3%).
Strabismus
The most frequently reported adverse events following injection of BOTOX®
for
strabismus include ptosis (15.7%) and vertical deviation (16.9%).
Primary Axillary Hyperhidrosis
The most frequently reported adverse events (3% to 10% of patients) following injection
of BOTOX®
for severe primary axillary hyperhidrosis include injection-site pain and
hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache,
fever, neck or back pain, pruritus, and anxiety.
Glabellar Lines
The most frequently reported adverse events following injection of BOTOX®
Cosmetic
include blepharoptosis and nausea.
14
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
15. ADVERSE REACTIONS (continued)
Overdosage
Excessive doses of BOTOX®
or BOTOX®
Cosmetic may be expected to produce
neuromuscular weakness with a variety of symptoms. Respiratory support may be
required where excessive doses cause paralysis of respiratory muscles. In the event
of overdose, the patient should be medically monitored for symptoms of excessive
muscle weakness or muscle paralysis.
In the event of suspected or actual overdosage, please contact your local or state health
department to process a request for antitoxin through the Centers for Disease Control
and Prevention (CDC). If you do not receive a response within 30 minutes, please
contact the CDC directly at 1-770-488-7100.
Note to representative: Please provide full BOTOX®
and BOTOX®
Cosmetic
Prescribing Information, including Medication Guide, when presenting
this material.
15
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
16. JUVÉDERM®
Important Safety Information
JUVÉDERM®
injectable gel (including JUVÉDERM®
Ultra,
JUVÉDERM®
Ultra Plus, JUVÉDERM®
Ultra XC, and JUVÉDERM®
Ultra Plus XC) is indicated for injection into the mid-to-deep dermis for
correction of moderate to severe facial wrinkles and folds (such as
nasolabial folds). Side effects were usually mild to moderate, lasting 7
days or less, and included 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.
17. BOTOX®
(onabotulinumtoxinA) and BOTOX®
Cosmetic
(onabotulinumtoxinA): Experience Worldwide
1. Data on file, Allergan, Inc.; 2. The American Society of Plastic Surgeons (ASPS). 2009 Report of the 2008 Statistics: National Clearinghouse of Plastic
Surgery Statistics. The American Society of Plastic Surgeons (ASPS) Web site. http://www.plasticsurgery.org/Media/stats/2008-US-cosmetic-reconstructive-
plastic-surgery-minimally-invasive-statistics.pdf. Accessed 2010.
17
19. Proven Treatment for Moderate to Severe
Glabellar Lines
First physician-administered, nonsurgical aesthetic treatment
approved by the FDA to temporarily treat moderate to severe
glabellar lines in patients 18-65 years of age
High levels of patient satisfaction1,2
– Precise delivery with physician control
– Predictable clinical outcomes3
Frown lines are caused by overactive facial muscles.
1. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX®
Cosmetic Use Survey, April 2005.; 2. Facial Injectables Consumer User Survey;
July 2009. 3. BOTOX®
Cosmetic Prescribing Information, August 2009.
20. Precise Control for Predictable Outcomes
In clinical trials at day 7, 74% of
patients demonstrated none or
mild glabellar line severity at
maximum frown as compared to
6% in placebo; at day 30, 80% of
patients demonstrated the same
as compared to 3% in placebo.1
Side effects associated with the
injection include localized pain,
infection, inflammation,
tenderness, swelling, redness,
and/or bleeding/bruising.
1. BOTOX®
Cosmetic Prescribing Information, August 2009.
Unretouched photos
taken at maximum frown
before treatment with
BOTOX®
Cosmetic and
taken at maximum frown
after treatment with
BOTOX®
Cosmetic at days 2
and 14. The photos
featured here are of actual
BOTOX®
Cosmetic patients.
Individual results may vary.
Before Day 14Day 2
20
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
22. 74
80
70
48
25
82
89
82
63
39
6 3 2 2 2
9 7 4 3 1
7 30a 60 90 120 7 30a 60 90 120
BOTOX Cosmetic (onabotulinumtoxinA) (N = 405) Placebo (N = 132)
BOTOX®
Cosmetic (onabotulinumtoxinA):
74% “Full Response” by Day 71
aDay 30: Co-primary efficacy time point, P < .001.
1. BOTOX®
Cosmetic Prescribing Information, August 2009.
Day of Investigator’s Assessment Day of Subject’s Assessment
®
Responders(%)
22
23. Patient Satisfaction Is Paramount in Aesthetic Practices
1. Fagien S, et al. Plast Reconstr Surg. 2008.
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
24. BOTOX®
Cosmetic (onabotulinumtoxinA):
97% Patient Satisfaction in Surveyed Patients1,2
1. Facial Injectables Consumer User Survey; July 2009; 2. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX®
Cosmetic Use Survey,
April 2005.
24
Very Satisfied
69.2%
Somewhat Satisfied
27.4%Not Satisfied
3.4%
Self-reported responses
N = 117
25. Why High Satisfaction With BOTOX®
Cosmetic
(onabotulinumtoxinA)
1. The American Society of Plastic Surgeons (ASPS) Web site. Accessed 2010; 2. BOTOX®
Cosmetic Prescribing Information, 2009.
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
26. BOTOX®
Cosmetic (onabotulinumtoxinA): A Specific
Formulation Not Shared by Any Other Product
≈ 5 nanograms of onabotulinumtoxinA,
≈ 900-kDa neurotoxin complex
0.9 mg sodium chloride
0.5 mg serum albumin
27. BOTOX®
Cosmetic (onabotulinumtoxinA):
A Legacy of Experience
1. The American Society of Plastic Surgeons (ASPS) Web site. Accessed 2010; 2. Aesthetic Surgery Education and Research Foundation (ASERF),
BOTOX®
Cosmetic Use Survey, April 2005; 3. Facial Injectables Consumer User Survey; July 2009; 4. BOTOX®
Cosmetic Prescribing Information, 2009.
27
28. Summary of FDA Labeling Changes to
BOTOX®
Cosmetic (onabotulinumtoxinA)
Unique nonproprietary name
Addition of Boxed Warning regarding distant spread of toxin effect
– No definitive reports of distant spread of toxin effect with
BOTOX®
Cosmeticat the labeled dose of 20 U
Revised lack of interchangeability
Statement of nondetectability of BOTOX®
Cosmetic in peripheral blood
Revised content regarding:
– Pre-existing neuromuscular disorders
– Dysphagia and breathing difficulties in the treatment of cervical dystonia
– Information for patients/provision of approved patient Medication Guide
by physician
– Adverse reactions regarding local weakness of muscles adjacent
to injection
– Overdosage including the addition of new text and instructions
28
29. Summary of BOTOX®
Cosmetic (onabotulinumtoxinA)
Risk Evaluation and Mitigation Strategies (REMS)
29
• Medication Guide
– Included in each carton
– Notice to distribute Medication Guide to patient
– Additional copies of Medication Guide available from Allergan
• Communication Plan
– Support healthcare providers in the implementation of REMS
– “Dear Healthcare Provider” Letter (DHPL)
– DHPL, updated prescribing information, and Medication Guide provided to all
BOTOX®
/BOTOX®
Cosmetic (onabotulinumtoxinA) purchasers
Please see BOTOX®
Cosmetic Important Safety Information
including Boxed Warning on slides 7-15.
30. Allergan’s Proactive Steps to Protect Patient Safety
Importation of
pharmaceuticals
and biologic
products into the
United States has
drawn media
attention
Direct-to-physician
sales help ensure
product integrity
Exacta®
vial to
ensure product
authenticity
• Flip-top cap and purple-
colored crimp
• ALLERGAN appears on
the holographic label
31. Importation of Foreign Pharmaceuticals or Biologics Into
the United States Without FDA Approval Remains Illegal
Please see BOTOX®
Cosmetic Important Safety
Information including Boxed Warning on slides 7-15.
32. Botulinum Toxin Units Are Not Interchangeable
According to the Label
1. BOTOX® Cosmetic Prescribing Information, 2009; 2. Dysport™ Prescribing Information, 2009.
32
“…Units of biological
activity of
BOTOX®
Cosmetic cannot
be compared to or
converted into Units of any
other botulinum toxin…”1
“…Units of biological
activity of
BOTOX®
Cosmetic cannot
be compared to or
converted into Units of any
other botulinum toxin…”1
“The potency Units of
Dysport™ are specific to
the preparation and assay
method utilized. They are
not interchangeable with
other preparations
of botulinum
toxin products…”2
“The potency Units of
Dysport™ are specific to
the preparation and assay
method utilized. They are
not interchangeable with
other preparations
of botulinum
toxin products…”2
33. Evaluating Botulinum Toxin Properties
1. BOTOX®
Cosmetic Prescribing Information, 2009; 2. Dysport™ Prescribing Information, 2009; 3. Lietzow et al. Protein J. 2008; 4. Hambleton. J Neurol.
1992.; 5. Wenzel et al. J Clin Pharm Ther. 2007; 6. Panjwani et al. Botulinum J. 2008.
BOTOX®
Cosmetic
(onabotulinumtoxinA)
(2002)
Dysport™
(abobotulinumtoxinA)
(1991)
BoNT A
SNAP-251
BoNT A
SNAP-252
≈ 9003
≥ 3004
Vacuum-dried
NaCl
Albumin1
Freeze-dried2
Lactose2
Albumin2
Neutral5
Neutral5
100 U1
300 U/500 U2
≈ 5 ng5 4.35 ng per 500 LD50 U6
2.5 mL per 100 U1
1.5 mL per 300 U
or
2.5 mL per 300 U2
20 U
4 U per .01 mL x 51
50 U2
10 U per .05 mL x 52
or 10
U per .08 mL x 52
33
Serotype/SubstrateSerotype/Substrate
Complex weight (kDa)Complex weight (kDa)
FormulationFormulation
pHpH
Units/VialUnits/Vial
Total ProteinTotal Protein
(ng/vial)(ng/vial)
ReconstitutionReconstitution
Approved doseApproved dose
34. Botulinum Toxin Injection Patterns Vary
1. BOTOX®
Cosmetic Prescribing Information, 2009; 2. Moy et al. Arch Facial Plastic Surg. 2009.
34
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
35. Botulinum Toxins Perform Differently: Results From a
Double-Blind, Randomized, Parallel-Group Study1
1. Lowe et al. J Am Acad Dermatol. 2006.
35
36. Glabellar Line Severity Improved With
BOTOX®
Cosmetic (onabotulinumtoxinA)1
Duration from a double-blind, randomized, parallel-group study.
Incidence of at least a 1-grade improvement from baseline in
glabellar line severity at maximum contraction.
1. Lowe et al. J Am Acad Dermatol. 2006.
94%
(29/31)
77%
(24/31)
53%
(16/30)
97%
(29/30)
59%
(17/29)
28%
(8/29)
0
20
40
60
80
100
8 12 16
P = .04
Patients(%)
Weeks
BOTOX®
Cosmetic (onabotulinumtoxinA) (20 U)
Dysport™
(abobotulinumtoxinA) (50 U)
36
37. Considerations in Switching to Another
Botulinum Toxin
Physicians considering switching to another botulinum
toxin need to evaluate:
Differences in the approved dose, dilution, volume, and
injection sites
Potential side effects
Patients considering treatment with another botulinum
toxin need to evaluate:
Experience of injector with specific toxin
Side effects with specific toxin
Effectiveness of specific toxin
37
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
38. The Science of LATISSE®
(bimatoprost ophthalmic solution) 0.03%
At Allergan Medical, we have seen a market evolution in the way facial aesthetics is defined, led by opinion leaders such as yourselves. We have moved from treating dynamic lines by reducing muscle activity to filling in static lines and folds, to restoration of lost volume. Most recently, we are using both toxin and fillers for facial shaping and contouring. Our aim is to provide best-in-class products that offer practitioners the opportunity to select the right product for the right patient need.
In slightly more than 100 years, knowledge of Botulinum Toxin Type A has expanded from the identification of the bacterium Clostridium botulinum to the commercialization of BOTOX ® (onabotulinumtoxinA). In 1989, BOTOX ® was approved by the FDA (at that time the product was called Oculinum). Allergan conducted the clinical trials leading to this approval, and in 1991 acquired Oculinum, Inc., and obtained approval to change the product name to BOTOX ® .
References 1. Data on file, Allergan, Inc. 2. The American Society of Plastic Surgeons (ASPS). 2009 Report of the 2008 Statistics: National Clearinghouse of Plastic Surgery Statistics. The American Society of Plastic Surgeons (ASPS) Web site. http://www.plasticsurgery.org/Media/stats/2008-US-cosmetic-reconstructive-plastic-surgery-minimally-invasive-statistics.pdf. Accessed 2010.
BOTOX ® Cosmetic (onabotulinumtoxinA) is the first botulinum toxin to receive approval by the US Food and Drug Administration (FDA) for the temporary treatment of moderate to severe glabellar lines. References 1. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX ® Cosmetic Use Survey, April 2005. 2. Facial Injectables Consumer User Survey; July 2009. 3. BOTOX ® Cosmetic Prescribing Information, August 2009.
With proper dosing of 20 Units in the glabellar region, the effects of treatment can last up to 4 months. 1 Treatment with BOTOX ® Cosmetic (onabotulinumtoxinA) can be repeated as long as the patient continues to respond and there are no allergic reactions. References BOTOX ® Cosmetic Prescribing Information, August 2009.
References BOTOX ® Cosmetic Prescribing Information, August 2009.
Investigator’s assessment of glabellar line severity at maximum frown–responder rates (percentage of subjects with severity of none or mild). Subject’s assessment of change in appearance of glabellar lines–responder rates (percentage of subjects with at least moderate improvement). References BOTOX ® Cosmetic Prescribing Information, August 2009.
References Fagen S, Carrthers, JDA. A comprehensive review of patient-reported satisfaction with botulinum toxin type A for aesthetic procedures. Plast Reconstr Surg. 2008;122(6):1915-1925.
References 1. Facial Injectables Consumer User Survey; July 2009. 2. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX ® Cosmetic Use Survey, April 2005.
References 1. The American Society of Plastic Surgeons (ASPS). 2009 Report of the 2008 Statistics: National Clearinghouse of Plastic Surgery Statistics. The American Society of Plastic Surgeons (ASPS) Web site. http://www.plasticsurgery.org/Media/stats/2008-US-cosmetic-reconstructive-plastic-surgery-minimally-invasive-statistics.pdf. Accessed December, 2009. 2. BOTOX ® Cosmetic Prescribing Information, August 2009.
References 1. The American Society of Plastic Surgeons (ASPS). 2009 Report of the 2008 Statistics: National Clearinghouse of Plastic Surgery Statistics. The American Society of Plastic Surgeons (ASPS) Web site. http://www.plasticsurgery.org/Media/stats/2008-US-cosmetic-reconstructive-plastic-surgery-minimally-invasive-statistics.pdf. Accessed December, 2009. 2. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX ® Cosmetic Use Survey, April 2005. 3. Facial Injectables Consumer User Survey, July 2009. 4. BOTOX ® Cosmetic Prescribing Information, August 2009.
Due to clear differences between commercial botulinum toxin products, imparted through the manufacturing and formulation process, the FDA has mandated specific language in product labeling stating that Units of biological activity are not interchangeable nor simply converted between products. References 1. BOTOX ® Cosmetic Prescribing Information, August 2009. 2. Dysport ™ Prescribing Information, 2009.
References 1. BOTOX ® Cosmetic Prescribing Information, August 2009. 2. Dysport ™ Prescribing Information, 2009. Lietzow MA, Gielow ET, Le D, Zhang J, Verhagen MF. Subunit stoichiometry of the Clostridium botulinum type A neurotoxin complex determined using denaturing capillary electrophoresis. Protein J. 2008;27(7-8):420-425. 3. Hambleton P. Clostridium botulinum toxins: a general review of involvement in disease, structure, mode of action and preparation for clinical use. J Neurol. 1992;239(1):16-20. 4. Wenzel R, Jones D, Borrego JA. Comparing two botulinum toxin type A formulations using manufacturers’ product summaries. J Clin Pharm Ther. 2007;32(4):387-402. 5. Panjwani N, O’Keeffe R, Picket A. Biochemical, functional and potency characteristics of type A botulinum toxin in clinical use. Botulinum J. 2008;1(1):153-166.
References 1. BOTOX ® Cosmetic Prescribing Information, August 2009. 2. Moy R, Maas C, Monheit G, Huber MB; for Reloxin ® Investigational Group. Long-term safety and efficacy of a new botulinum toxin type A in treating glabellar lines. Arch Facial Plast Surg. 2009;11(2):77-83.
References 1. Lowe P, Patnaik R, Lowe N. Comparison of two formulations of botulinum toxin type A for the treatment of glabellar lines: a double-blind, randomized study. J Am Acad Dermatol. 2006;55(6):975-980.
References 1. Lowe P, Patnaik R, Lowe N. Comparison of two formulations of botulinum toxin type A for the treatment of glabellar lines: a double-blind, randomized study. J Am Acad Dermatol. 2006;55(6):975-980.