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
Thursday, 17 April 2008
Akorn got USFDA Approval of Ofloxacin Ophthalmic Solution USP, 0.3%
Posted by ADKS at 2:48 pm