The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Trusopt
Ophthalmic Solution, 2%, of Merck Sharp & Dohme Corp.
This technique resulted in the development of second generation CAIs such as dorzolamide (Trusopt
) andbrinzolamide (Azopt).
Dorzolamide Dorzolamide Conjunctival 2% 5ml BC hyperaemia, (20mg/ml) Trusopt
pain, diplopia, 2%, 5mL BC taste disorders, 2% Unit dose Preservative free depression.
(21.) Manufacturer's Information: Trusopt
These products include a variety of chemotherapy and therapeutic pharmaceuticals designed to combat cancer (i.e., Cisplatin, Carboplatin, Neupogen), an artificial lung for use with newborn children, anti-glaucoma ophthalmic eye drops (Trusopt
) and even the well known calcium supplement Citrical (Council on Government Relations, 1999).
Carbonic anhydrase inhibitors include brinzolamide (Azopt), which has no human eye data, and dorzolamide (Trusopt
), which has growth restriction in one case treated with fixed combination of dorzolamide and timolol.
The deal with Santen includes ophthalmology products COSOPT, COSOPT PF, TRUSOPT
PF, TIMOPTIC TIMOPTIC PF, TIMOPTIC XE and TAPTIQOM, with combined sales of some USD400m in the markets within the scope of the agreement, the companies said.
Brinzolamide (Azopt) and dorzolamide (Trusopt
) are used for glaucoma and ocular hypertension.
Implant type Materials Drug loaded Biodegradable PLGA 50:50 Ethacrynic acid (ECA) PLGA film Biodegradable PCL + PCL + Lutrol F 127 Trusopt
(Dorzolamide Lutrol F 127 disk Hydrochloride) Microspheres 50: 50 blend of PLGA Timolol Maleate 502H + PLA Liposomes Dipalmitoylphospha- Latanoprost tidylcholine (DPPC) lipids Duration of Delivery Implant type drug release method Reference Biodegradable 10 days Implanted in  PLGA film sclera Biodegradable PCL + 6 months-1 year Subconjunctival  Lutrol F 127 disk implantation Microspheres 3-4 months Subconjunctival  injection Liposomes 2-3 months Subconjunctival  injection TABLE 2: Examples of sustained release delivery systems for glaucoma that are under clinical development.
In October 2008 Hi-Tech was granted final approval for dorzolamide hydrochloride ophthalmic solution and dorzolamide hydrochloride with timolol maleate ophthalmic solution, generic equivalents of Merck & Co.'s Trusopt
and Cosopt, indicated for the treatment of glaucoma.
, Reduces Frequent Do not use if you Azopt amount of urination, have an allergy or aqueous tingling sensitivity to humor sensation in sulfa drugs.