Besivance

NDA 22308, held by Bausch And Lomb. Besifloxacin Hydrochloride.

As of Nov 13, 2026, NDA 22308 (Besivance), held by Bausch And Lomb, was first approved by FDA on May 28, 2009, with 9 approved supplements and 0 published complete response letters.

First approved: May 28, 2009
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

BESIVANCE (besifloxacin ophthalmic suspension) 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans* CDC coryneform group G Corynebacterium pseudodiphtheriticum* Corynebacterium striatum* Haemophilus influenzae Moraxella catarrhalis* Moraxella lacunata* Pseudomonas aeruginosa* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus hominis* Staphylococcus lugdunensis* Staphylococcus warneri* Streptococcus mitis group Streptococcus oralis Streptococcus pneumoniae Streptococcus salivarius* *Efficacy for this organism was studied in fewer than 10 infections.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Sep 18, 2012	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 28, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
BesivanceEQ 0.6% BASE · suspension/drops;ophthalmic	Besifloxacin Hydrochloride	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Apr 3, 2018	Supplement 13Labeling · Standard review	Approved	Label Letter
Nov 10, 2015	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 7, 2015	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 5, 2014	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 30, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 14, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 16, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
May 10, 2013	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 18, 2012	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 28, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 22308
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters