History of RhoGAM^® Brand

Hemolytic Disease of the Newborn (HDN) [also known as Hemolytic Disease of the Fetus and Newborn (HDFN)]
Before Rh Immune Globulin (RhoGAM^®), HDFN claimed the lives of 10,000 babies in the US every year. RhoGAM^® was introduced in 1968 and it quickly proved to be simple, safe and effective. In the years since the introduction of Rh Immune Globulin, cases of Hemolytic Disease of the Newborn due to anti-D are extremely rare in the developed world.

The creation of RhoGAM^® was the result of years of collaborative work by Dr. Gorman and Dr. Freda from Columbia University in New York, NY and a scientist from Ortho Research Foundation, Dr. Pollack. The conception of this unique product was possible due to the earlier ground breaking clinical research that defined the etiology of the disease and also led to bringing the Coombs test to market by Dr. Phillip Levine and colleagues. In 1980, Dr. Gorman and his colleagues, Dr. Freda and Dr. Pollack received the Lasker Clinical Medical Research Award for their breakthrough research.

Today, the use of Rh Immune Globulin to protect babies of Rh negative mothers is the standard of practice around the world. In fact, RhoGAM^® has been recognized as one of the greatest accomplishments in obstetrics and gynecology in the past 50 years by Dr. Charles Lockwood, chair of the American College of Obstetricians and Gynecologists' Committee on Obstetric Practice.

Historical Timeline

1939- Dr. Philip Levine and Dr. R.E. Stetson published a paper showing that baby-mother group incompatibility is the cause of Hemolytic Disease of the Newborn.

1945- Coombs, Mourant and Race developed first assay to detect antibodies in sera of Rh-negative patients

1950- Introduced to market the Coombs test to identify sensitized Rh-negative patients

1968- Introduced to market RhoGAM^®, the first Rh Immune Globulin product to treat Hemolytic Disease of the Newborn.

1975- Dr. J.G. Gorman published "The role of the Laboratory in Hemolytic Disease of the Newborn" Lea and Febiger, Philadelphia

1980- Dr. Gorman and his colleagues, Dr. Freda and Dr. Pollack, received the Lasker Clinical Medical Research Award for this breakthrough research.

Complete Prescribing Information for RhoGAM® Ultra-Filtered PLUS