CEQUA (Page 2 of 2)

14 CLINICAL STUDIES

Two multicenter, randomized, adequate and well-controlled clinical studies treated 1,048 patients with keratoconjunctivitis sicca (NCT # 02254265 and NCT # 02688556). In both studies, compared to vehicle at Day 84, there was a statistically significant (p<0.01) higher percentage of eyes with increases of ≥ 10 mm from baseline in Schirmer wetting. This effect was seen in approximately 17% of CEQUA-treated patients versus approximately 9% of vehicle-treated patients.

Tear Production

OTX-101-2014-001

OTX-101-2016-001

CEQUA

N=152

Vehicle

N=152

CEQUA

N=371

Vehicle

N=373

≥ 10-mm increase in tear production

(% of eyes) at Day 84

16.8%

8.6%

16.6%

9.2%

Difference (95% CI)

8.2% (1.9%, 14.6%)

7.3% (3.3%, 11.3%)

p-value versus vehicle

<0.01

<0.01

16 HOW SUPPLIED/STORAGE AND HANDLING

CEQUA ophthalmic solution is packaged in sterile, preservative-free, single-use vials. Each vial

contains 0.25 mL fill in a 0.9 mL LDPE vial; 10 vials (2 cards of 5 vials) are packaged in a

polyfoil aluminum pouch; 6 pouches are packaged in a box. The entire contents of each box of

60 vials must be dispensed intact.

60 Single-Use Vials 0.25 mL each — NDC 47335-506-96

Storage: Store at 20°C to 25°C (68°F to 77°F). Store single-use vials in the original foil pouch.

17 PATIENT COUNSELING INFORMATION

Handling the Vial

Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may

contaminate the solution. Advise patients also not to touch the vial tip to their eye to avoid the

potential for injury to the eye [see Warnings and Precautions ( 5.1)].

Use with Contact Lenses

CEQUA should not be administered while wearing contact lenses. Patients with decreased tear

production typically should not wear contact lenses. Advise patients that if contact lenses are

worn, they should be removed prior to the administration of the solution. Lenses may be

reinserted 15 minutes following administration of CEQUA ophthalmic solution [see Warnings

and Precautions ( 5.2)].

Administration

Advise patients that the solution from one individual single-use vial is to be used immediately

after opening for administration to one or both eyes, and the remaining contents should be

discarded immediately after administration.

Rx Only

Manufactured for: Sun Pharmaceutical Industries Limited

By: Laboratoire Unither

1 rue de l’Arquerie

50200 Coutances

France

Cyclosporine (active ingred.) Product of Czech Republic.

Product of France

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Copyright 2022, Sun Pharmaceutical Industries Limited

All rights reserved

07/2022

uspi-CEQUA-sol-00004

PRINCIPAL DISPLAY PANEL

NDC 47355-506-96

For topical use in the eye
sterile, Preservative-Free

Cequa ®
(cyclosporine ophthalmic solution) 0.09%

60 SINGLE-USE VIALS

6 pouches x 10 single-use vials (0.25 mL each)

Rx only

Keep out of reach of children.
Not child resistant.

SUN PHARMA

Image
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 47355-507-97

For topical use in the eye
sterile, Preservative-Free

Cequa ®
(cyclosporine ophthalmic solution) 0.09%

10 SINGLE-USE SAMPLE VIALS

1 pouches x 10 single-use vials (0.25 mL each)

Rx only

Keep out of reach of children.
Not child resistant.

SUN PHARMA

image1
(click image for full-size original)
CEQUA
cyclosporine solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-506
Route of Administration OPHTHALMIC, TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOSPORINE (CYCLOSPORINE) CYCLOSPORINE 0.0009 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 40 HYDROGENATED CASTOR OIL 0.01 g in 1 mL
OCTOXYNOL-40 0.0005 g in 1 mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 0.0053 g in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 0.0047 g in 1 mL
SODIUM CHLORIDE 0.0005 g in 1 mL
POVIDONE K90 0.003 g in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-506-96 6 POUCH in 1 BOX contains a POUCH
1 10 VIAL, SINGLE-DOSE in 1 POUCH This package is contained within the BOX (47335-506-96) and contains a VIAL, SINGLE-DOSE
1 0.25 mL in 1 VIAL, SINGLE-DOSE This package is contained within a POUCH and a BOX (47335-506-96)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210913 08/15/2018
CEQUA
cyclosporine solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-507
Route of Administration OPHTHALMIC, TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOSPORINE (CYCLOSPORINE) CYCLOSPORINE 0.0009 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 40 HYDROGENATED CASTOR OIL 0.01 g in 1 mL
OCTOXYNOL-40 0.0005 g in 1 mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 0.0053 g in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 0.0047 g in 1 mL
SODIUM CHLORIDE 0.0005 g in 1 mL
POVIDONE K90 0.003 g in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-507-97 1 POUCH in 1 BOX contains a POUCH
1 10 VIAL, SINGLE-DOSE in 1 POUCH This package is contained within the BOX (47335-507-97) and contains a VIAL, SINGLE-DOSE
1 0.25 mL in 1 VIAL, SINGLE-DOSE This package is contained within a POUCH and a BOX (47335-507-97)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210913 08/15/2018
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Registrant — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Laboratoire Unither 574139809 manufacture (47335-506), manufacture (47335-507)
Establishment
Name Address ID/FEI Operations
Teva Czech Industries s.r.o 643896244 api manufacture (47335-506), api manufacture (47335-507)

Revised: 04/2023 Sun Pharmaceutical Industries, Inc.

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