Caplin Point Laboratories Ltd’s subsidiary, Caplin Steriles Ltd reported that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ofloxacin Otic Solution 0.3%.
It is a generic therapeutic equivalent version of the Reference Listed Drug (RLD), FLOXIN Otic Solution of Daiichi Pharmaceuticals Inc. Ofloxacin Otic Solution 0.3% is used as an antibacterial for ear use. According to IQVIATM (IMS Health), Ofloxacin Otic Solution 0.3% had US sales of approximately $36 million for the 12-month period ending June 2023.
The company reported that it developed and filed 37 ANDAs in the USA on its own and with partners, with 25 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products that it intends to file over the next 4 years.
The shares were down by 0.84 per cent to ₹1,388.70 at 2:51 pm on the BSE.