Caplin Steriles gets USFDA approval for Ofloxacin Otic Solution

Caplin Steriles has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ofloxacin Otic Solution 0.3%, a generic therapeutic equivalent version of (RLD), FLOXIN Otic Solution of Daiichi Pharmaceuticals Inc.

Ofloxacin Otic Solution 0.3% is used as anti-infective (antibacterial) for otic (ear) use. According to IQVIA (IMS Health), Ofloxacin Otic Solution 0.3% had US sales of approximately $36 million for the 12-month period ending June 2023.