Available EU DMF/CEP
EU DMF
CEP
API Status
Commercial
Pipeline
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
Respiratory system
Available US DMF
US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
Korean DMF

Etodolac

CAS No.

41340-25-4

Innovator/marketer

Lodine SR, Eccoxolac

Polymorphic form

Crystalline racemate, none

Therapeutic Area

Musculo-skeletal system

Status

Commercial

EU DMF readiness

US DMF readiness

011405

CEP

Other documentation

Japanese DMF
Korean DMF - under registration

Drug description:

Etodolac belongs to anti-inflammatory drugs (NSAIDs).
Etodolac is indicated for acute or long term use in: osteoarthritis, rheumatoid arthritis. Etodolac is used to treat pain or inflammation caused by arthritis.
It is formulated as hard capsules, tablets in sustained release formulation, film-coated tablets for oral route of administration.

Mechanism of action:
Etodolac is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic actions. Etodolac is an inhibitor of the cyclooxygenase enzyme (COX) involved in prostaglandin synthesis. Etodolac is an selective inhibitor of COX-2.

DISCLAIMER
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).

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