FDA Approves Color Change for Prozac 10-milligram Capsule

Business Wire, June 2, 1995

INDIANAPOLIS--(HealthWire)--June 2, 1995--Eli Lilly and Co. announced today that the 10-milligram version of its antidepressant Prozac(R) soon will be available in a different color to more easily distinguish it from the 20-milligram capsule, which remains the standard dosage for most patients.

Lilly had sought the change in response to suggestions from some customers--including patients and pharmacists--for increased differentiation between the two dosage forms. The U.S. Food and Drug Administration cleared the modification for marketing following a review process of only six weeks.

``This is a prime example of Lilly listening to its customers and responding to their needs,'' said Timothy R. Franson, M.D., executive director of North American regulatory affairs for Lilly. ``Our desire to make this change in a timely manner was heightened because of increasing use of the 10-milligram capsule by physicians, who are finding it to be a valuable tool for varying patients' dosage in some individual cases. We commend the FDA for responding so promptly to our request.''

Currently, the 20-milligram capsule is half cream and half light green, while the 10-milligram capsule is half gray and half light green. By contrast, the new 10-milligram capsule will be entirely light green.

Prozac, the world's top-selling antidepressant, has been used by more than 16 million patients worldwide and is available in more than 80 countries. The product was launched in the United States in January 1988 in the 20-milligram dosage form. Since that time, the FDA has cleared for marketing a liquid formulation and the 10-milligram capsule.

One 20-milligram capsule per day remains the therapeutic dose for most patients for the treatment of depression, said Freda C. Lewis-Hall, M.D., a Lilly clinical research physician for central-nervous-system disorders. But she emphasized that physicians are increasingly recognizing the usefulness of the 10-milligram formulation.

``The 10-milligram capsule provides physicians with the flexibility of changing the dosage of the medication according to a specific patient's needs,'' Lewis-Hall said. ``Just as no two patients are alike, approaches to treating them can be tailored to their individual circumstances.''

Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., that is working with its customers worldwide to help ensure that diseases are prevented, managed and cured with maximum benefit and minimum cost to patients and society. -0-

Prozac(R) (fluoxetine hydrochloride, Dista)

CONTACT: Eli Lilly & Company, Indianapolis

Victoria Murphy, 317/276-3254