skip to main content

Lindane Facts: The Truth About Lindane

Lindane Product Advancements

Ongoing Lindane Research Investments

As a U.S. manufacturer of lindane medications, Morton Grove Pharmaceuticals, Inc. (MGP) recognizes the public health need to preserve lindane as a second-line therapy for the treatment of scabies and lice. Given that the majority of lindane safety issues relate to the potential for misuse, MGP has taken important measures to minimize this risk—and continues to do so.

Working in close collaboration with regulatory experts, MGP has taken the lead in developing and implementing a lindane clinical research program. This ongoing investment is designed to further enhance the benefit-safety balance of lindane medications.

The current lindane research program has multiple goals1

Advancing lindane safety remains a priority

MGP has played an integral role in improving the safety of lindane medications for patients in the U.S. The company is proud of its work with regulatory experts at the Food and Drug Administration (FDA), and continues to look for new ways to enhance the safety and clinical utility of lindane medications through research and development efforts.

Lindane safety advancements implemented by MGP2–7

Single-use packaging: Modified from the original 16 oz. bottle to small, single-use, 2 oz. bottles of lindane lotion and lindane shampoo

Boxed warnings: Updated lindane label for healthcare professionals, highlighting important risks (including neurologic toxicities) and patient selection criteria

Patient-friendly lindane medication guide: Packaged with each bottle and required by law to be dispensed by pharmacists with each lindane prescription to educate patients and caregivers on risks and appropriate use

Please See Important Safety Information on Lindane

References:

  1. Murphy MD. (Director, FDA Office of Pediatric Drug Development). “Re: ANDA 88-190, ANDA 88-191.” Correspondence to Morton Grove Pharmaceuticals. September 30, 2003.
  2. Lindane lotion, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.fda.gov/cder/foi/label/2003/006309lotionlbl.pdf.
  3. Lindane shampoo, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.fda.gov/cder/foi/label/2003/006309shampoolbl.pdf.
  4. Medication Guide Lindane Lotion USP, 1%. Updated March 28, 2003. Available at: http://www.fda.gov/cder/drug/infopage/lindane/lindaneLotionGuide.htm.
  5. Medication Guide Lindane Shampoo USP, 1%. Updated March 28, 2003. Available at: http://www.fda.gov/cder/drug/infopage/lindane/lindaneShampooGuide.htm.
  6. U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research (CDER) Report to the Nation: 2003. Available at: http://www.fda.gov/cder/reports/rtn/2003/rtn2003-3.htm.
  7. U.S. Food and Drug Administration (FDA). Public health advisory: Safety of topical lindane products for the treatment of scabies and lice. March 28, 2003. Available at: http://www.fda.gov/cder/drug/infopage/lindane/lindanePHA.htm.