Thursday 17 April, 2008

Akorn got USFDA Approval of Ofloxacin Ophthalmic Solution USP, 0.3%

Akorn announced that the USFDA has granted approval to ANDA for Ofloxacin Ophthalmic Solution USP, 0.3%.
Ofloxacin ((+/-)-9-fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)- 7-oxo-7H-pyrido [1,2,3-de]-1, 4-benzoxazine-6-carboxylic acid) Ophthalmic Solution (generic form of Allergen pharma 's OCUFLOX, which was approved on July 30, 1993) is an anti-infective used to treat infections caused by bacteria in conjunctivitis and corneal ulcers. Annual sales for Ofloxacin were approximately $7.5 million in 2007, according to IMS sales data. There following are generic players in US market for this formulation:
1. BAUSCH AND LOMB
2. ALCON
3. AKORN
4. NOVEX
5. APOTEX
6. HI TECH PHARMA
7. PHARMAFORCE
8. ALCON

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