FDA Approves Generic Lidocaine Ointment

SunGen Pharma has received FDA approval for an abbreviated new drug application approval for Lidocaine Ointment USP, 5%. The drug product is used for the production of anesthesia of accessible mucous membranes of the oropharynx.

The product is also used as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.

Lidocaine has annual sales of about $60 million.

REFERENCE

SunGen Pharma receives eighth ANDA approval from US FDA [news release]. Princeton, NJ; October 31, 2019: Globe Newswire. https://www.globenewswire.com/news-release/2019/10/31/1939048/0/en/SunGen-Pharma-Receives-Eighth-ANDA-Approval-from-US-FDA.html. Accessed October 31, 2019.