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BRISTOL-MYERS SQUIBB COMPANY RE-INTRODUCES NYDRAZID(R) INJECTION TO COMBAT RISE IN TUBERCULOSIS

 PRINCETON, N.J., Feb. 16 /PRNewswire/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that Nydrazid(R) Injection (Isoniazid Injection USP) has been cleared by the U.S. Food & Drug Administration (FDA) for re-entry into the U.S. pharmaceutical market.
 Nydrazid Injection is an anti-infective drug indicated for the treatment of all susceptible forms of tuberculosis. Nydrazid Injection is currently available for physician prescribing and will be marketed by the company's Apothecon division.
 In response to a recent rise in the number of tuberculosis cases nationwide, the FDA and the Centers for Disease Control (CDC) had asked Bristol-Myers Squibb Company to re-introduce Nydrazid Injection and to reinstate production of the product as quickly as possible. The company and the FDA worked very closely together to bring the product to the market. Since Bristol-Myers Squibb Company is the only company that manufactures the injectable form of Nydrazid, the FDA expedited the drug-approval process in order to meet the urgent public health need. The supplemental new drug application (SNDA) was filed on Dec. 9, 1992, and the SNDA was approved, within an unusually short time period, on Dec. 31, 1992.
 Bristol-Myers Squibb Company marketed Nydrazid Injection (Isoniazid Injection USP) from 1952 until 1992 when it was discontinued, because the supplier of the raw material was no longer available and the demand for the product had significantly declined. A new supplier for the raw material has been identified by the FDA, and Bristol-Myers Squibb Company has performed the requisite testing to qualify the source.
 Dr. Mark Goldberger, division of Antiviral Drug Products for the U.S. Food & Drug Administration, said, "We are giving high priority to maintaining adequate supplies of the products needed to treat tuberculosis. We are quite pleased that Bristol-Myers Squibb Company resumed production and distribution of Nydrazid Injection as quickly as they did."
 "The FDA's cooperative support during the qualification studies and its speed in approving Nydrazid's application demonstrate the aggressive efforts that are being made to ensure the re-introduction of effective, well-established therapies as tuberculosis makes a comeback in the United States," said Lee Burg, vice president and general manager of Apothecon.
 Tuberculosis is a highly contagious disease characterized by lesions on the lungs. The disease usually spreads through the inhalation of infectious drops from coughs and can be transmitted easily to immune- compromised patients, including patients with acquired immune deficiency syndrome (AIDS) and human immuno-deficiency virus (HIV) infection.
 The number of new tuberculosis cases in the United States has been in decline through the mid-1980s, until the resurgence associated with the AIDS epidemic. According to the CDC, the incidence of tuberculosis has risen 18 percent since 1988. The CDC reported more than 26,000 new cases of tuberculosis in 1991.
 According to Dr. Walter G. Jump, director of Medical and Regulatory Affairs for Apothecon, "This is an excellent example of government and industry working together to respond quickly to help stem an escalating health crisis. Nydrazid Injection (Isoniazid Injection USP) should be a tremendous help in the fight against tuberculosis."
 Nydrazid is a standard medical treatment for tuberculosis. Available by prescription only, in tablets, syrup and injectable forms, it is administered in a daily dose of 5 mg/kg in adults and 10 mg/kg in children. Nydrazid Injection often is used in combination therapy with other anti-tuberculosis agents to increase its effectiveness. It cures the disease by killing the bacteria that cause tuberculosis. However, patients must take the medication over a long period of time (anywhere from six months to two years) even after the symptoms have abated, because the bacteria multiply slowly, and relapse rates are extremely high when therapy is discontinued prematurely.
 The most frequent adverse events associated with Nydrazid Injection (Isoniazid Injection USP) are those affecting the liver and central nervous system. Toxicity usually is seen only in patients requiring high doses. Severe and sometimes fatal hepatitis associated with Nydrazid Injection therapy may occur and may develop even after many months of treatment. The risk of developing hepatitis is age related.
 The FDA requested the re-introduction of Nydrazid Injection in the belief that the injectable form will benefit patients who cannot take oral therapy for tuberculosis. Administration by injection also may provide better bioavailability (rapid transport of the drug's active ingredient into the infected areas) than oral forms. Nydrazid Injection also may enhance patient compliance with tuberculosis therapy since the initial dose, and perhaps subsequent dosing, often is administered in a physician's office or hospital.
 "While Nydrazid Injection is not a major product for Bristol-Myers Squibb Company, we are very pleased to be in a position to re-introduce it into the United States market in order to meet the needs of HIV, AIDS and other immune-comprised patients," said Burg.
 Apothecon, a Bristol-Myers Squibb Company, is dedicated to serving the needs of the pharmacy profession. Apothecon offers pharmacists a wide variety of key off-patient, multi-source products at competitive prices and with a high degree of customer service. Apothecon markets a broad line of pharmaceutical and over-the-counter products.
 Bristol-Myers Squibb Company is a research-based, diversified healthcare company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is among the world's leading makers of cardiovascular, anticancer, anti-infective, central nervous system and dermatological drug therapies, diagnostic agents and non-prescription medications.
 /delval/
 -0- 2/16/93
 /Editors: Additional background information on tuberculosis and Nydrazid Injection is available upon request./
 /CONTACT: Patrick Donohue of Bristol-Myers Squibb, 609-252-5685, or Kathy Loehrig or Nancy Farwell, 609-778-0380, both of Anne Klein & Associates, for Bristol-Myers Squibb/
 (BMY)


CO: Bristol-Myers Squibb Company ST: New Jersey IN: MTC SU:

MJ-MK -- PH003 -- 6708 02/16/93 08:38 EST
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Date:Feb 16, 1993
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