Framycetin

Overview

A component of neomycin that is produced by Streptomyces fradiae. On hydrolysis it yields neamine and neobiosamine B. (From Merck Index, 11th ed)

Indication

For the treatment of bacterial blepharitis, bacterial bonjunctivitis, corneal injuries, corneal ulcers and meibomianitis. For the prophylaxis of ocular infections following foreign body removal

Associated Conditions

Acute Crusting Rhinitis
Conjunctivitis
Corneal Abrasions
Infection
Stye
Ulcerative keratitis
Acute rhino-sinusitis
Bacterial blepharitis
Bacterial skin infections
Nasal carriage of staphylococci

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
PROCTOSEDYL OINTMENT	Bausch Health Companies Inc.	SIN01718P	OINTMENT	1% w/w	6/8/1988

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SOFRAMYCIN framycetin 5mg/mL (as sulfate) ear and eye drops bottle	47541	Pharmaco Australia Ltd	Medicine	A	1/7/1994
Sofradex Ear Drops	157804	Sanofi-Aventis Australia Pty Ltd	Medicine	A	12/12/2008
OTODEX EAR DROPS dexamethasone (as sodium metasulfobenzoate) framycetin sulfate gramicidin 8 mL bottle	43840	Pharmaco Australia Ltd	Medicine	A	4/1/1993
SOFRADEX EAR DROPS dexamethasone (as sodium metasulfobenzoate) framycetin sulfate gramicidin 8 mL bottle	13539	Pharmaco Australia Ltd	Medicine	A	8/30/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PROCTOSEDYL OINTMENT	hoechst roussel canada inc.	01988549	Ointment - Rectal	10 MG / G	12/31/1971
SOFRAMYCIN EYE DROPS 5MG/ML	roussel canada inc.	00026921	Drops - Ophthalmic	5 MG / ML	12/31/1966
SANDOZ OPTICORT	Sandoz Canada, Inc.	02247920	Solution - Otic , Ophthalmic	5 MG / ML	1/16/2004
TEVA-PROCTOSONE	teva canada limited	02226391	Suppository - Rectal	10 MG	12/30/1996
SOFRACORT STERILE EAR/EYE DROPS	hoechst roussel canada inc.	01987712	Drops - Topical	5 MG / ML	12/31/1966
PROCTOSEDYL	Aptalis Pharma Canada ULC	02223252	Ointment - Rectal	1 %	4/1/2003
PROCTOSEDYL SUP	roussel canada inc.	00173622	Suppository - Rectal	10 MG	12/31/1959
SOFRACORT EYE/EAR DROPS	roussel canada inc.	00228052	Drops - Ophthalmic , Otic	5 MG / ML	12/31/1966
SOFRAMYCIN STERILE EYE OINTMENT	searchlight pharma inc	02224895	Ointment - Ophthalmic	5 MG / G	8/3/2001
SOFRAMYCIN STERILE EYE OINTMENT 0.5%	hoechst roussel canada inc.	01987666	Ointment - Ophthalmic	5 MG / G	12/31/1995

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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