`PharmaDerm, A division of Fougera Pharmaceuticals Inc.
`----------
`
`HIGHLIGHTS OF PRESCRIBING INFORMATION
`These highlights do not include all the information needed to use KERYDIN safely and effectively. See full
`prescribing information for KERYDIN.
`®
`KERYDIN (tavaborole) topical solution, 5%
`INITIAL U.S. APPROVAL: 2014
`
`INDICATIONS AND USAGE
`KERYDIN is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to
`Trichophyton rubrum or Trichophyton mentagrophytes. (1)
`DOSAGE AND ADMINISTRATION
`Apply KERYDIN to affected toenails once daily for 48 weeks. (2)
`KERYDIN should be applied to the entire toenail surface and under the tip of each toenail being treated. (2)
`For topical use only. (2)
`Not for oral, ophthalmic, or intravaginal use. (2)
`
`Solution, 5%. (3)
`
`None. (4)
`
`DOSAGE FORMS AND STRENGTHS
`
`CONTRAINDICATIONS
`
`ADVERSE REACTIONS
`Common adverse reactions occurring in ≥1% in subjects treated with KERYDIN included application site exfoliation,
`ingrown toenail, application site erythema, and application site dermatitis. (6.1)
`To report SUSPECTED ADVERSE REACTIONS, contact Anacor Pharmaceuticals at 1-844-4ANACOR [1-844-
`426-2267] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
`See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
`
`Revised: 3/2015
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`1 INDICATIONS AND USAGE
`2 DOSAGE AND ADMINISTRATION
`3 DOSAGE FORMS AND STRENGTHS
`4 CONTRAINDICATIONS
`6 ADVERSE REACTIONS
`6.1 Clinical Trials Experience
`7 DRUG INTERACTIONS
`8 USE IN SPECIFIC POPULATIONS
`8.1 Pregnancy
`8.3 Nursing Mothers
`8.4 Pediatric Use
`8.5 Geriatric Use
`11 DESCRIPTION
`12 CLINICAL PHARMACOLOGY
`12.1 Mechanism of Action
`12.2 Pharmacodynamics
`12.3 Pharmacokinetics
`12.4 Microbiology
`13 NONCLINICAL TOXICOLOGY
`13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`
`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2001 - 1/12
`
`
`
`14 CLINICAL STUDIES
`16 HOW SUPPLIED/STORAGE AND HANDLING
`16.1 How Supplied
`16.2 Storage and Handling
`17 PATIENT COUNSELING INFORMATION
`*
`Sections or subsections omitted from the full prescribing information are not listed.
`
`FULL PRESCRIBING INFORMATION
`
`1 INDICATIONS AND USAGE
`KERYDIN (tavaborole) topical solution, 5% is an oxaborole antifungal indicated for the treatment of
`onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
`
`2 DOSAGE AND ADMINISTRATION
`Apply KERYDIN to affected toenails once daily for 48 weeks.
`KERYDIN should be applied to the entire toenail surface and under the tip of each toenail being treated.
`KERYDIN is for topical use only and not for oral, ophthalmic, or intravaginal use.
`
`3 DOSAGE FORMS AND STRENGTHS
`KERYDIN topical solution, 5% is a clear, colorless alcohol-based solution. Each milliliter of solution
`contains 43.5 mg (5% w/w) of tavaborole.
`
`4 CONTRAINDICATIONS
`None.
`
`6 ADVERSE REACTIONS
`
`6.1 Clinical Trials Experience
`Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed
`in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug
`and may not reflect the rates observed in practice.
`In two clinical trials, 791 subjects were treated with KERYDIN. The most commonly reported adverse
`reactions are listed below (Table 1).
`
`Table 1: Adverse Reactions Occurring in ≥1% of KERYDIN Topical Solution, 5%-Treated
`Subjects and at a Greater Frequency than Observed with Vehicle
`KERYDIN
`N=791
`n(%)
`21 (2.7%)
`20 (2.5%)
`13 (1.6%)
`10 (1.3%)
`
`Preferred Term
`Application site exfoliation
`Ingrown toenail
`Application site erythema
`Application site dermatitis
`
`Vehicle
`N=395
`n(%)
`1 (0.3%)
`1 (0.3%)
`0 (0%)
`0 (0%)
`
`ANACOR EX. 2001 - 2/12
`
`
`
`Application site dermatitis
`
`10 (1.3%)
`
`0 (0%)
`
`A cumulative irritancy study revealed the potential for KERYDIN to cause skin irritation. There was no
`evidence that KERYDIN causes contact sensitization.
`
`7 DRUG INTERACTIONS
`In vitro studies have shown that tavaborole, at therapeutic concentrations, neither inhibits nor induces
`cytochrome P450 (CYP450) enzymes.
`
`8 USE IN SPECIFIC POPULATIONS
`
`8.1 Pregnancy
`Pregnancy Category C
`There are no adequate and well-controlled studies with KERYDIN in pregnant women. KERYDIN
`should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
`Systemic embryofetal development studies were conducted in rats and rabbits and a dermal embryofetal
`development study was conducted in rabbits.
`Oral administration:
`In an oral embryofetal development study in rats, oral doses of 30, 100, and 300 mg/kg/day tavaborole
`were administered during the period of organogenesis (gestational days 6-19) to pregnant female rats.
`In the presence of maternal toxicity, embryofetal toxicity (increased embryofetal resorption and/or
`deaths) and drug-related skeletal malformations and variations suggestive of delayed development (i.e.,
`a delay in ossification) were noted in fetuses at 300 mg/kg/day tavaborole [570 times the Maximum
`Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons]. No
`developmental toxicity was noted in rats at 100 mg/kg/day tavaborole (26 times the MRHD based on
`AUC comparisons).
`In an oral embryofetal development study in rabbits, oral doses of 15, 50, and 150 mg/kg/day tavaborole
`were administered during the period of organogenesis (gestational days 7-19) to pregnant female
`rabbits. In the presence of maternal toxicity, excessive embryofetal mortality due to post-implantation
`loss was noted at 150 mg/kg/day tavaborole. No drug related malformations were noted in rabbits at 150
`mg/kg/day tavaborole (155 times the MRHD based on AUC comparisons). No embryofetal mortality was
`noted in rabbits at 50 mg/kg/day tavaborole (16 times the MRHD based on AUC comparisons).
`Topical administration:
`In a dermal embryofetal development study in rabbits, topical doses of 1%, 5%, and 10% tavaborole
`solution were administered during the period of organogenesis (gestational days 6-28) to pregnant
`female rabbits. A dose dependent increase in dermal irritation at the treatment site was noted at 5% and
`10% tavaborole solution. A decrease in fetal bodyweight was noted at 10% tavaborole solution. No
`drug related malformations were noted in rabbits at 10% tavaborole solution (36 times the MRHD based
`on AUC comparisons). No embryofetal toxicity was noted in rabbits at 5% tavaborole solution (26 times
`the MRHD based on AUC comparisons).
`Nonteratogenic effects:
`In an oral pre- and post-natal development study in rats, oral doses of 15, 60, and 100 mg/kg/day
`tavaborole were administered from the beginning of organogenesis (gestation day 6) through the end of
`lactation (lactation day 20). In the presence of minimal maternal toxicity, no embryofetal toxicity or
`effects on postnatal development were noted at 100 mg/kg/day (29 times the MRHD based on AUC
`comparisons).
`
`8.3 Nursing Mothers
`
`ANACOR EX. 2001 - 3/12
`
`
`
`It is not known whether tavaborole is excreted in human milk following topical application of
`KERYDIN. Because many drugs are excreted in human milk, caution should be exercised when
`KERYDIN is administered to a nursing woman.
`
`8.4 Pediatric Use
`Safety and effectiveness in pediatric patients have not been established.
`
`8.5 Geriatric Use
`In clinical trials of 791 subjects who were exposed to KERYDIN, 19% were 65 years of age and over,
`while 4% were 75 years of age and over. No overall differences in safety or effectiveness were
`observed between these subjects and younger subjects, but greater sensitivity of some older individuals
`cannot be ruled out.
`
`11 DESCRIPTION
`KERYDIN (tavaborole) topical solution, 5% contains tavaborole, 5% (w/w) in a clear, colorless
`alcohol-based solution for topical use. The active ingredient, tavaborole, is an oxaborole antifungal
`with the chemical name of 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole. The chemical formula
`is C H BFO , the molecular weight is 151.93 and the structural formula is:
`7 6
`2
`
`Tavaborole is a white to off-white powder. It is slightly soluble in water and freely soluble in ethanol
`and propylene glycol.
`Each mL of KERYDIN contains 43.5 mg of tavaborole. Inactive ingredients include alcohol, edetate
`calcium disodium, and propylene glycol.
`
`12 CLINICAL PHARMACOLOGY
`
`12.1 Mechanism of Action
`KERYDIN is an oxaborole antifungal [see Clinical Pharmacology (12.4)].
`
`12.2 Pharmacodynamics
`At therapeutic doses, KERYDIN is not expected to prolong QTc to any clinically relevant extent.
`
`12.3 Pharmacokinetics
`Tavaborole undergoes extensive metabolism. Renal excretion is the major route of elimination.
`In a clinical pharmacology trial of six healthy adult male volunteers who received a single topical
`14
`application of 5% C-tavaborole solution, tavaborole conjugates and metabolites were shown to be
`excreted primarily in the urine.
`The pharmacokinetics of tavaborole was investigated in 24 subjects with distal subungual
`onychomycosis involving at least 4 toenails (including at least 1 great toenail) following a single dose
`and a 2-week daily topical application of 200 μL of a 5% solution of tavaborole to all ten toenails and 2
`mm of skin surrounding each toenail. Steady state was achieved after 14 days of dosing. After a single
`dose, the mean (± standard deviation) peak concentration (C
`) of tavaborole was 3.54 ± 2.26 ng/mL
`max
`
`ANACOR EX. 2001 - 4/12
`
`
`
`max
`(n=21 with measurable concentrations, range 0.618-10.2 ng/mL, LLOQ=0.5 ng/mL), and the mean
`AUC was 44.4 ± 25.5 ng*hr/mL (n=21). After 2 weeks of daily dosing, the mean C
` was 5.17 ±
`last
`max
`3.47 ng/mL (n=24, range 1.51-12.8 ng/mL), and the mean AUC was 75.8 ± 44.5 ng*hr/mL.
`τ
`
`12.4 Microbiology
`Mechanism of Action
`The mechanism of action of tavaborole is inhibition of fungal protein synthesis. Tavaborole inhibits
`protein synthesis by inhibition of an aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS).
`Activity in vitro and in clinical infections
`Tavaborole has been shown to be active against most strains of the following microorganisms, both in
`vitro and in clinical infections [see Indications and Usage (1)]:
`Trichophyton rubrum
`Trichophyton mentagrophytes
`Mechanism of Resistance
`Trichophyton mentagrophytes and Trichophyton rubrum strains from isolates collected in the clinical
`trials have not demonstrated resistance following repeated exposure to tavaborole.
`
`13 NONCLINICAL TOXICOLOGY
`
`13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`In an oral carcinogenicity study in Sprague-Dawley rats, oral doses of 12.5, 25, and 50 mg/kg/day
`tavaborole were administered to rats once daily for 104 weeks. No drug related neoplastic findings
`were noted at oral doses up to 50 mg/kg/day tavaborole (14 times the MRHD based on AUC
`comparisons).
`In a dermal carcinogenicity study in CD-1 mice, topical doses of 5%, 10%, and 15% tavaborole solution
`were administered to mice once daily for 104 weeks. No drug related neoplastic findings were noted at
`topical doses up to 15% tavaborole solution (89 times the MRHD based on AUC comparisons).
`Tavaborole revealed no evidence of mutagenic or clastogenic potential based on the results of two in
`vitro genotoxicity tests (Ames assay and Human lymphocyte chromosomal aberration assay) and one in
`vivo genotoxicity test (rat micronucleus assay).
`No effects on fertility were observed in male and female rats that were administered oral doses up to
`300 mg/kg/day tavaborole (107 times the MRHD based on AUC comparisons) prior to and during early
`pregnancy.
`
`14 CLINICAL STUDIES
`The efficacy and safety of KERYDIN was evaluated in two multicenter, double-blind, randomized,
`vehicle-controlled trials. KERYDIN or vehicle was applied once daily for 48 weeks in subjects with
`20% to 60% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix)
`involvement.
`A total of 1194 subjects (795 KERYDIN, 399 Vehicle) 18 to 88 years of age, 82% male, 84% white,
`participated in these two trials. Efficacy assessments were made at 52 weeks following a 48-week
`treatment period.
`The Complete Cure efficacy endpoint included negative mycology (negative KOH wet mount and
`negative fungal culture) and Completely Clear Nail (no clinical evidence of onychomycosis as
`evidenced by a normal toenail plate, no onycholysis, and no subungual hyperkeratosis). Efficacy results
`
`ANACOR EX. 2001 - 5/12
`
`
`
`from the two trials are summarized in Table 2.
`
`Table 2: Efficacy Outcomes
`Trial 2
`Trial 1
`KERYDIN
`Vehicle
`KERYDIN
`Vehicle
`N=399
`N=194
`N=396
`N=205
`n(%)
`n(%)
`n(%)
`n(%)
`Efficacy Variable
`a
`3 (1.5%)
`36 (9.1%)
`1 (0.5%)
`26 (6.5%)
`Complete Cure
`8 (3.9%)
`71 (17.9%)
`3 (1.5%)
`61 (15.3%)
`Complete or Almost Complete Cure
`c
`Mycologic Cure
`124 (31.1%)
`14 (7.2%)
`142 (35.9%)
`25 (12.2%)
`a. Complete cure defined as 0% clinical involvement of the target toenail plus negative KOH and negative culture.
`b. Complete or almost complete cure defined as ≤10% affected target toenail area involved and negative KOH and
`culture.
`c. Mycologic cure defined as negative KOH and negative culture.
`
`b
`
`16 HOW SUPPLIED/STORAGE AND HANDLING
`
`16.1 How Supplied
`KERYDIN (tavaborole) topical solution, 5% is a clear, colorless solution supplied in an amber glass
`bottle with a screw cap. At initial use, the screw cap is replaced with the dropper assembly.
`KERYDIN (tavaborole) topical solution, 5% is supplied in the following presentations:
`NDC 10337-905-10: One bottle containing 10 mL of solution with one glass pointed-tip dropper.
`NDC 10337-905-44: One bottle containing 4 mL of solution with one glass pointed-tip dropper.
`
`16.2 Storage and Handling
`Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room
`Temperature].
`CAUTION: Flammable. Keep away from heat and flame.
`Discard product within 3 months after insertion of the dropper.
`Keep bottle tightly closed. Keep out of reach of children.
`
`17 PATIENT COUNSELING INFORMATION
`See FDA-approved patient labeling (Patient Information and Instructions for Use)
`The patient should be told the following:
`Use KERYDIN as directed by a health care professional.
`KERYDIN is for external use only. Avoid contact with eyes, mouth, or vagina. Avoid contact with
`skin other than skin immediately surrounding the treated nail(s). Wipe away excess solution from
`surrounding skin.
`Clean and dry nails prior to KERYDIN use. KERYDIN should be applied to completely cover the
`nail surface and also applied under the tip of each nail being treated. Allow solution to dry
`following application.
`The impact of nail polish or other cosmetic nail products on the efficacy of KERYDIN has not been
`evaluated.
`Inform a health care professional if the area of application shows signs of persistent irritation (for
`example, redness, itching, swelling).
`Forty-eight (48) weeks of daily application with tavaborole is considered the full treatment for
`
`ANACOR EX. 2001 - 6/12
`
`
`
`toenail onychomycosis.
`Do not use KERYDIN for any disorder other than that for which it is prescribed.
`Product is flammable. Avoid use near heat or open flame.
`
`________________________________________________________________________
`Manufactured for:
`Anacor Pharmaceuticals, Inc.
`Palo Alto, CA 94303 USA
`Distributed by:
`
`A division of Fougera Pharmaceuticals Inc.
`Melville, New York 11747 USA
`Issued: 03/2015
`®
`KERYDIN is a trademark of Anacor Pharmaceuticals, Inc.
`© 2015 Anacor Pharmaceuticals, Inc.
`U.S. Patent Nos. 7,767,657 and 7,582,621
`
`PATIENT INFORMATION
`®
`KERYDIN (ker' i din)
`(tavaborole) Topical Solution, 5%
`Important information: KERYDIN is for use on toenails only. Do not use KERYDIN in your mouth,
`eyes, or vagina.
`What is KERYDIN?
`KERYDIN is a prescription medicine used to treat fungal infections of the toenails.
`It is not known if KERYDIN is safe and effective in children.
`What should I tell my healthcare provider before using KERYDIN?
`Before using KERYDIN, tell your healthcare provider about all of your medical conditions, including
`if you:
`are pregnant or plan to become pregnant. It is not known if KERYDIN can harm your unborn baby.
`are breastfeeding or plan to breastfeed. It is not known if KERYDIN passes into your breast milk.
`
`Tell your healthcare provider about all the medicines you take, including prescription and over-the-
`counter medicines, vitamins, and herbal supplements.
`How should I use KERYDIN?
`See the “Instructions for Use” at the end of this Patient Information for detailed information
`about the right way to use KERYDIN.
`Use KERYDIN exactly as your healthcare provider tells you to use it.
`Apply KERYDIN to your affected toenails 1 time each day.
`KERYDIN is used for 48 weeks.
`It is not known if the use of nail polish or other cosmetic nail products (such as gel nails or acrylic
`nails) will affect how KERYDIN works.
`
`What should I avoid while using KERYDIN?
`Avoid getting KERYDIN on skin that is not surrounding the treated toenail.
`KERYDIN is flammable. Avoid heat and flame while applying KERYDIN to your toenail.
`
`What are the possible side effects of KERYDIN?
`KERYDIN may cause irritation at the treated site. The most common side effects include: skin peeling,
`ingrown toenail, redness, itching, and swelling. Tell your healthcare provider if you have any side
`
`ANACOR EX. 2001 - 7/12
`
`
`
`effect that bothers you or does not go away.
`These are not all of the possible side effects of KERYDIN.
`Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-
`FDA-1088.
`How should I store KERYDIN?
`Store KERYDIN at room temperature, between 68°F to 77°F (20°C to 25°C).
`KERYDIN is flammable. Keep away from heat and flame.
`Keep the bottle tightly closed.
`Safely throw away KERYDIN after 3 months of inserting the dropper.
`
`Keep KERYDIN and all medicines out of the reach of children.
`General information about the safe and effective use of KERYDIN
`Medicines are sometimes prescribed for purposes other than those listed in a Patient Information
`leaflet. You can ask your pharmacist or healthcare provider for information about KERYDIN that is
`written for health professionals. Do not use KERYDIN for a condition for which it was not prescribed.
`Do not give KERYDIN to other people, even if they have the same symptoms that you have. It may harm
`them.
`What are the ingredients in KERYDIN?
`Active ingredient: tavaborole
`Inactive ingredients: alcohol, propylene glycol, and edetate calcium disodium
`Manufactured for: Anacor Pharmaceuticals, Inc., Palo Alto, CA, 94303 USA
`®
`Distributed by: PharmaDerm , a division of Fougera Pharmaceuticals, Inc., Melville, New York 11747
`USA
`®
`For more information, call PharmaDerm , a division of Fougera Pharmaceuticals, Inc., at 1-800-
`645-9833.
`This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 03/2015
`
`Instructions for Use
`®
`KERYDIN (ker' i din)
`(tavaborole) Topical Solution, 5%
`
`Important information: KERYDIN is for use on toenails only. Do not use KERYDIN in your mouth,
`eyes, or vagina.
`
`Read the Instructions for Use that comes with KERYDIN before you start using it. Talk to your
`healthcare provider if you have any questions.
`How to apply KERYDIN:
`Your toenails should be clean and dry before you apply KERYDIN.
`Step 1: Before you apply KERYDIN to your affected toenail for the first time, remove the cap from the
`KERYDIN bottle. (See Figure A) Throw away the cap.
`Step 2: Remove the wrapping from the dropper that comes with KERYDIN. Insert the dropper into the
`KERYDIN bottle. (See Figure B)
`
`ANACOR EX. 2001 - 8/12
`
`
`
`Fig ure A Fig ure B
`Only apply KERYDIN using the provided dropper. Do not use the dropper for any other purpose.
`Step 3: With the dropper inserted into the KERYDIN, squeeze the bulb and then release the bulb to draw
`KERYDIN into the dropper.
`Step 4: Remove the dropper from the bottle and hold the dropper tip over your affected toenail.
`Step 5: Slowly squeeze the bulb to apply KERYDIN to your toenail. Apply enough solution to
`completely cover your toenail. You may need to use more than one drop. (See Figure C)
`
`Fig ure C
`Step 6: Use the dropper tip to gently spread KERYDIN to cover the entire toenail up to the edges of the
`toenail. (See Figure D)
`
`ANACOR EX. 2001 - 9/12
`
`
`
`Fig ure D
`Step 7: In addition to the top of the toenail, also apply KERYDIN under the tip of the toenail. Use the
`dropper tip to gently spread KERYDIN under the entire tip of the toenail. (See Figures E and F)
`
`Fig ure E Fig ure F
`Step 8: Repeat Steps 3 to 7 to apply KERYDIN to each affected toenail.
`Step 9: Let the KERYDIN dry completely. This may take a couple of minutes.
`If KERYDIN comes in contact with surrounding skin, use a tissue to wipe any excess solution from the
`surrounding skin. Do not wipe KERYDIN off of your toenails.
`Step 10: After applying KERYDIN to your toenails, insert the dropper back into the bottle and screw it
`on tightly.
`Step 11: Wash your hands with soap and water after applying KERYDIN.
`This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug
`Administration.
`Manufactured for: Anacor Pharmaceuticals, Inc., Palo Alto, CA, 94303 USA
`®
`Distributed by: PharmaDerm , a division of Fougera Pharmaceuticals, Inc., Melville, New York 11747
`USA
`
`ANACOR EX. 2001 - 10/12
`
`
`
`Issued: 03/2015
`Principal Display Panel - Representative Packaging
`PharmaDerm® NDC 10337-905-10
`Kerydin™
`(TAVABOROLE)
`TOPICAL SOLUTION, 5%
`For Topical Use Only
`Not for oral, ophthalmic,
`or intravaginal use
`10 mL
`Rx only
`
`ANACOR EX. 2001 - 11/12
`
`
`
`KERYDIN
`tavaborole solution
`
`Product Information
`Product T ype
`
`HUMAN PRESCRIPTION DRUG
`
`Ite m Code (Source )
`
`NDC:10 337-9 0 5
`
`Route of Administration
`
`TOPICAL
`
`DEA Sche dule
`
`
`
`Active Ingredient/Active Moiety
`Ingredient Name
`Ta va bo ro le (UNII: K124A4EUQ3) (Tavabo ro le - UNII:K124A4EUQ3)
`
`Basis of Strength
`Tavabo ro le
`
`Strength
`43.5 mg in 1 mL
`
`Inactive Ingredients
`
`Ingredient Name
`
`Strength
`
`Alco ho l (UNII: 3K9 9 58 V9 0 M)
`Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)
`Edeta te Ca lcium Diso dium (UNII: 25IH6 R4SGF)
`
`
`
`
`
`Packaging
`
`#
`
`Item Code
`
`1 NDC:10 337-9 0 5-
`10
`
`1 in 1 CARTON
`
`Package Description
`
`Marketing Start
`Date
`
`Marketing End
`Date
`
`1
`
`10 mL in 1 BOTTLE, WITH APPLICATOR; Type 0 : No t a
`Co mbinatio n Pro duct
`
`2 NDC:10 337-9 0 5-
`44
`
`1 in 1 CARTON
`
`2
`
`4 mL in 1 BOTTLE, WITH APPLICATOR; Type 0 : No t a Co mbinatio n
`Pro duct
`
`Marketing Information
`Marke ting Cate gory
`Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
`NDA
`NDA20 4427
`0 7/0 7/20 14
`
`Labeler - PharmaDerm, A division of Fougera Pharmaceuticals Inc. (043838424)
`
`Revised: 3/2015
`
`
`
`PharmaDerm, A division of Fougera Pharmaceuticals Inc.
`
`ANACOR EX. 2001 - 12/12