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
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
CEQUA cyclosporine solution/ drops | ||||||||||||||||||||||
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CEQUA cyclosporine solution/ drops | ||||||||||||||||||||||
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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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