Caraco anticipates ANDA approvals.DETROIT, Mich.--(HealthWire)--Aug. 1, 1996--Caraco Pharmaceutical Laboratories, Ltd. (BULLETIN BOARD:CARA CARA Chicago Area Runners Association CARA Center for Applied Research in the Apostolate (Washington, DC) CARA Center for Astrophysical Research in Antarctica CARA Classification and Rating Administration ) today announced that it anticipates receiving several ANDA ANDA abbr. abbreviated new drug application approvals before year end. Following a site inspection by the Detroit District Office of the 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. ), Caraco received notice that the Detroit Office was recommending to the Center for Drug Evaluation (CDER CDER Center for Drug Evaluation and Research (US FDA) CDER Centre de Développement des Energies Renouvelables (French) CDER Client Development and Evaluation Report ) that the firm be approved to manufacture two products for which they had made submissions. A third product reviewed by the District is still under evaluation by the CDER. The bioequivalency study for this product has been accepted. Caraco expects to resolve the outstanding chemistry questions shortly. CDER makes the final decisions concerning approval of these submissions. The two products which received District clearance are an anti-tubercular drug and an antibiotic currently being used, as reported in the New York Times, for treatment of an AIDS related disease. The New York Times article indicated, that since the use of this drug was not for a label indicated condition, insurance companies were not covering its cost, thereby forcing the patient to pay for the medication out of his own pocket. This will be the first generic approval for this drug. Caraco, also announced, that it is scheduled to begin bioequivalency studies on a non-steroidal anti-inflammatory drug Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs, are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation. it has developed. If successful, upon completion of these clinical studies, Caraco will file an ANDA for this product. William R. Hurd, President & Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. , stated that, "It is very gratifying to see our labors come to fruition like this. The successful outcome of the inspections of our facility are a tribute to the skill, hard work, and dedication of all Caraco employees." Caraco Pharmaceutical Laboratories, Ltd. is engaged in developing, manufacturing and marketing generic drugs for the ethical and over-the-counter markets. In August 1995, the Company signed a distribution agreement with leading pharmaceutical and health care product distributor McKesson Drug Company, a subsidiary of $13 billion McKesson Corp. (NYSE NYSE See: New York Stock Exchange :MCK), which provides Caraco with access to McKesson's existing distribution networks. Among Caraco's 14 generic products, are Nifedipine nifedipine /ni·fed·i·pine/ (ni-fed´i-pen) a calcium channel blocking agent used as a coronary vasodilator in the treatment of coronary insufficiency and angina pectoris; also used in the treatment of hypertension. , a calcium blocker for the cardiovascular market, SureLac(TM), a lactase enzyme tablet which permits enjoyment of dairy products without discomfort; and additional products used for pain relief, sleeplessness, and coughs and colds. CONTACT: Caraco Pharmaceutical Laboratories, Ltd., Detroit William R. Hurd, 313/871-8400 |
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