King Pharmaceuticals Announces FDA Approval of New Bicillin(R) Manufacturing Facility.New Plant and Delivery System for Bicillin([R]) L-A, Preferred Treatment for Syphilis, Comes at a Time When Syphilis Rates Are Rapidly Resurging after near Elimination BRISTOL, Tenn. -- King Pharmaceuticals, Inc. (NYSE NYSE See: New York Stock Exchange : KG) announced today the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approval of the Company's new state-of-the-art manufacturing and production facility in Rochester, Michigan for its Bicillin([R]) product line. Bicillin([R]) L-A (penicillin G benzathine penicillin G benzathine Bicillin L-A, Megacillin (CA), Permapen Pharmacologic class: Penicillin Therapeutic class: Anti-infective Pregnancy risk category B Actioninjectable suspension) is the first product available from this facility.The recent Sexually Transmitted Diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely Treatment Guidelines issued in 2006 by the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation ) recommends penicillin G as the preferred treatment of all stages of syphilis. Bicillin([R]) L-A, administered via deep intramuscular injection, has been used effectively for more than 60 years to cure syphilis and prevent sexual transmission. "This modern facility demonstrates King's commitment to the continued importance of treating and controlling infectious diseases," stated Eric J. Bruce, Chief Technical Operations Officer, King Pharmaceuticals, Inc. "With syphilis on the rise in major cities across the U.S., the new facility expands our production capacity to ensure continued availability of Bicillin([R]) L-A to healthcare providers and patients." New Packaging/Delivery System To streamline the ease and use of Bicillin([R]) L-A, King is now using the Becton Dickinson Hypack[TM] Luer-Lok[TM] syringe system with the Eclipse[TM] safety-cover needle. The Bicillin([R]) L-A package carton contains five prefilled syringes per thermoform tray, two trays per carton and 10 needles individually sterilized and packaged. Bicillin([R]) L-A is available in 1mL Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. (600,000 units), 2mL (1,200,000 units) and 4mL (2,400,000 units). The average dose to treat primary, secondary and latent syphilis is 2,400,000 units in one single dose. Bicillin([R]) L-A is also indicated for mild-to-moderate infections of the upper respiratory tract due to susceptible streptococci, including streptococcal streptococcal /strep·to·coc·cal/ (-kok´al) pertaining to or caused by a streptococcus. Streptococcal (Streptococcus) Pertaining to any of the Streptococcus bacteria. pharyngitis, and has been used for prophylaxis to prevent recurrence of rheumatic fever and/or chorea chorea (kərē`ə, kō–) or St. Vitus's dance, acute disturbance of the central nervous system characterized by involuntary muscular movements of the face and extremities. . Alarming Increase in Syphilis Syphilis shows a significant increase in cities across the country. There were 8,852 new cases of primary and secondary syphilis reported at the end of 2006. "The overall increase in syphilis infections among adults and adolescents was driven by increases among at-risk males. The rates increased by 8.5 percent in 2005 -- 4.7 per 100,000 population in 2004 to 5.1 in 2005. And, for the first time in over a decade, the rate of syphilis has increased in women, underscoring the need for ongoing, effective medical prevention and treatment using penicillin G benzathine," said Jeffrey D. Klausner, M.D., M.P.H. Director, STD (Subscriber Trunk Dialing) Long distance dialing outside of the U.S. that does not require operator intervention. STD prefix codes are required and billing is based on call units, which are a fixed amount of money in the currency of that country. Prevention and Control Services, San Francisco Department of Public Health and Associate Clinical Professor of Medicine, University of California, San Francisco . About Syphilis Syphilis is a sexually transmitted disease sexually transmitted disease (STD) or venereal disease, term for infections acquired mainly through sexual contact. Five diseases were traditionally known as venereal diseases: gonorrhea, syphilis, and the less common granuloma inguinale, (STD) caused by the bacterium T. pallidum. It is passed from person to person through direct sexual contact with syphilis sore, or chancre chancre: see syphilis. chancre Primary sore or ulcer at the site of entry of a pathogen; specifically, the typical skin lesion of primary infectious syphilis. In women it is often internal and may go unnoticed. , which is painless and disappears in about three weeks. Many people infected with syphilis may not have any symptoms for years, or do not recognize a sore or rash during the early stages of the disease. As such, most transmission is from persons who are unaware of their infection. Left untreated, the disease may progress leading to organ damage and potentially, death. "As the only manufacturer of Bicillin([R]) L-A in the U.S., King recognizes its responsibility to healthcare clinicians and their patients. Through ongoing educational efforts, including audio conferences, newsletters and a new Web site, we will endeavor to keep clinicians up-to-date on prevention and treatment issues," said Charles L. Pamplin, III, M.D., Vice President of Medical Affairs for King Pharmaceuticals. About Bicillin([R]) L-A Bicillin([R]) L-A (penicillin G benzathine injectable suspension) is indicated for the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels provided by this particular dosage form including: syphilis, yaws, bejel and pinta Pinta Definition A bacterial infection of the skin which causes red to bluish-black colored spots. Description Pinta is a skin infection caused by the bacterium Treponema carateum . Penicillin G benzathine is contraindicated in individuals with hypersensitivity to any penicillin-type antibiotic. Use with caution in individuals with histories of significant allergies and/or asthma. Give only by deep intramuscular injection. Do not inject by any other route, such as intra-arterial or intravenous. Do not inject into or near nerves or blood vessels, since such injection might produce neurovascular or other damage. WARNING: NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX ad·mix tr. & intr.v. ad·mixed, ad·mix·ing, ad·mix·es To mix; blend. [Back-formation from obsolete admixt, mixed into, from Middle English, from Latin WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling. Please see full Prescribing Information which may be obtained at www.bicillin.net. About King Pharmaceuticals King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management. For more information about Bicillin([R]) L-A and syphilis, visit www.bicillin.net. |
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