Andrx Receives FDA Approval For Monopril-HCT.FORT LAUDERDALE, Fla. -- Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) ("Andrx") today announced that the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. ("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. ") has approved its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar ("ANDA ANDA abbr. abbreviated new drug application ") for bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. versions of Monopril-HCT(R) (Fosinopril Sodium fosinopril sodium Monopril, Staril (UK) Pharmacologic class: Angiotensin-converting enzyme (ACE) inhibitor Therapeutic class: Antihypertensive Pregnancy risk category C (first trimester), and Hydrochlorothiazide hydrochlorothiazide /hy·dro·chlo·ro·thi·a·zide/ (-klor?o-thi´ah-zid) a thiazide diuretic, used for treatment of hypertension and edema. hy·dro·chlo·ro·thi·a·zide n. Abbr. Tablets, 10mg/12.5mg and 20mg/12.5mg). According to IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. data, U.S. sales of Monopril-HCT(R) for the trailing 12 months were approximately $24 million. The FDA awarded Andrx a 180-day period of marketing exclusivity for this product. Due to Andrx's inability to launch the product at this time as a result of raw material issues with its supplier, Andrx entered into an Exclusivity Transfer Agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy"), which received a tentative approval for this product on September 1, 2004. Andrx agreed to waive its marketing exclusivity rights exclusively to Ranbaxy in exchange for a share of Ranbaxy's profits resulting from the sales of this product for a certain period of time. Ranbaxy anticipates its product will be launched promptly following receipt by Ranbaxy of final FDA approval of its ANDA for this product. Under the agreement, Andrx is entitled to launch its own version of this product, which Andrx will pursue. Andrx's 180-day marketing exclusivity period commenced when Bristol-Myers Squibb Company ("Bristol-Myers") failed to appeal the decision of the United States District Court United States District Court In the U.S., any of the 94 trial courts of general jurisdiction in the federal judicial system. Each state, as well as the District of Columbia and the Commonwealth of Puerto Rico, has at least one federal district court. that the Andrx product did not infringe the patents that cover Bristol-Myers' Monopril-HCT(R) product. About Andrx Corporation We are a pharmaceutical company that develops and commercializes generic versions of controlled-release brand name pharmaceuticals, using our proprietary controlled-release drug delivery technologies, and generic versions of niche and immediate-release brand pharmaceuticals, including oral contraceptives; distributes pharmaceuticals, primarily generics, manufactured by others as well as manufactured by us, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians' offices; and commercializes brand pharmaceuticals, in some instances using our proprietary controlled-release drug delivery technologies. About Ranbaxy Pharmaceuticals Inc. Ranbaxy Pharmaceuticals Inc. ("RPI RPI - Rockwell Protocol Interface ") based in Jacksonville, Florida, is the wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of Ranbaxy Laboratories Limited ("RLL (Run Length Limited) An encoding method commonly used on magnetic disks, including RLL, IDE, SCSI, ESDI, SMD and IPI interfaces. The actual number of bits recorded on the disk is greater than the data bits. "), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system. Ranbaxy Laboratories Limited, India's largest pharmaceutical company, manufactures and markets brand and generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 34 countries and manufacturing operations in 7 countries. Forward-looking statements (statements which are not historical facts) in this report are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. For this purpose, any statements contained herein or which are otherwise made by us or on our behalf that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including but not limited to, our dependence on a relatively small number of products; licensing revenues; the timing and outcome of patent, antitrust and other litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. ; the timing and commercial success of future product approvals and launches including generic versions of Monopril-HCT(R), whether ours or Ranbaxy's; whether we will be awarded any market exclusivity period and, if so, the precise dates thereof; introduction of significant new generic products by others; government regulation generally, and FDA regulation, in particular, including quality standards for our products and facilities; competition; manufacturing capacities, output and quality processes; our ability to develop and successfully commercialize new products; the loss of revenues from existing products; development and marketing expenses that may not result in commercially successful products; our inability to obtain, or the high cost of obtaining, licenses for third party technologies; commercial obstacles to the successful introduction of brand products generally; exclusion of our brand products from formularies; the consolidation or loss of customers; our relationship to our suppliers; the success of our joint ventures; difficulties in integrating, and potentially significant charges associated with, acquisitions of technologies, products and businesses; the inability to obtain sufficient supplies from key suppliers; the impact of returns, allowances and chargebacks; product liability claims; rising costs and limited availability of product liability and other insurance; the loss of key personnel; hurricanes and other adverse weather conditions; failure to comply with environmental laws; and the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals. We are also subject to other risks detailed herein or detailed from time to time in our other filings with the SEC. We disclaim any intent or obligation to update the forward-looking statements as expressly required by law. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com. |
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