Chennai, January 08, 2024: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted 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 IQVIATM (IMS Health), Ofloxacin Otic Solution 0.3% had US sales of approximately $36 million for the 12-month period ending June 2023.