Regulatory Decision Summary for Otixal
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
This New Drug Submission (NDS) was submitted seeking approval of Otixal (ciprofloxacin hydrochloride 0.3% and fluocinolone acetonide 0.025%) otic solution for the treatment of acute otitis media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes. The sponsor also requested approval for the treatment of acute otitis externa (AOE) in pediatric (age 6 months and older), adult and elderly patients. The AOE indication was not approved due to lack of adequate scientific evidence.
Why was the decision issued?
The proposed single use combination formulation of an antibiotic and a topical steroid is expected to reduce the bacterial infection of the middle ear and its complications, in children with tympanostomy tubes. It also adds an additional option to the currently available option for treatment.
Systemic absorption of corticosteroids has been associated with teratogenicity in lab animals. Similarly, systemic absorption of ciprofloxacin is associated with fluoroquinolone related toxicities. Even though the risk of systemic absorption from topical application is very low, precautionary statements regarding these effects are included in the prescribing information.
Neurosensory deafness and labyrinth disorders have been observed in few patients during clinical trials with topical ciprofloxacin. A definitive causal relation has not yet been established due to insufficient number of reports. The sponsor has agreed to monitor these adverse reactions during post-marketing surveillance.
Overall, the benefit of using the proposed formulation for the treatment of AOMT outweighs the potential risks and uncertainties.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| OTIXAL | 02459655 | MEDEXUS PHARMACEUTICALS INC. | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 0.3 % / W/V FLUOCINOLONE ACETONIDE 0.025 % / W/V |