FDA Approves IGI Laboratories' Lidocaine Hydrochloride USP 4% Topical Solution

IGI Laboratories, Inc. announced via press release that the Food and Drug Administration (FDA) has approved its first pharmaceutical product, lidocaine hydrochloride USP 4% topical solution. The New Jersey based company received FDA approval in an Abbreviated New Drug Application (ANDA). The drug is indicated as an anesthetic for mucous membranes. Jason Grenfell-Gardner, President and CEO of the Company, said, "With now 13 further applications pending, and at least nine more filings planned this year, IGI will continue to execute its R&D plan as part of our goal of being a leading player in the generic topical pharmaceutical market."

Mucous Membranes

The mucous membranes become inflamed or irritated due to surgical procedures, tumors, from instruments during procedures like bronchoscopy, and from diseases like esophagitis. Membranes in the mouth, nasal cavity, and parts of the digestive tract are targets for pain relief.

Lidocaine Hydrochloride USP 4% Topical Solution

The lidocaine hydrochloride USP 4% topical solution inhibits ionic fluxes, stabilizing the neuronal membrane and initiating anesthetic action. The rate of absorption varies depending on the mucous membrane targeted, the dose, the concentration, and the amount of time exposed to the therapeutic agent. Intratracheal administration is most effective. When introduced into the gastrointestinal tract, the drug is well absorbed, but the drug does not circulate well because the liver transforms it.

ANDA Approval

The FDA issued IGI Laboratories its first drug approval. The Abbreviated New Drug Application (ANDA) was submitted to the FDA's Center for Drug Evaluation and Research, Office of Generic Drugs in May of 2012. This office reviews generic drug applications and issues approvals. Approval means that the sponsor of the drug is free to manufacture and market the drug.

Generic drugs are called “abbreviated” because they do not have to provide clinical data as did the sponsor of the brand name drug. The generic drug sponsor does have to demonstrate that the drug is “bioequivalent” to the innovator drug. The generic must be comparable in quality, strength, delivery method, and perform according to its intended use.

To measure bioequivalence and demonstrate efficacy to the FDA, scientists enlist healthy volunteers and calculate the time it takes for the generic to reach the bloodstream. This time frame shows the rate of absorption, which is then compared to the innovator drug’s rate of absorption.

About IGI Laboratories, Inc.

IGI Laboratories is a generic topical pharmaceutical company.  It develops and manufactures topical formulations for the pharmaceutical, OTC, and cosmetic markets. It’s mission is to be a leading player in the generic topical prescription drug market.