PRINCETON, N.J., Feb. 1 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Clarithromycin XL 1000 mg tablets. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined that Ranbaxy's formulation can be expected to have the same therapeutic effect as an equivalent dose of Biaxin XL Filmtab Extended Release tablets 500mg of Abbott Laboratories. Total annual market sales for oral Clarithromycin were $538.9 million (IMS - MAT: Sept. 2004). For the same period, Biaxin XL (Clarithromycin XL 500 mg tablets) accounted for approximately 60 percent of that market, with $320.5 million in sales.
Clarithromycin XL tablets are indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions as listed: Pharyngitis/Tonsillitis due to Streptococcus pyogenes; Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae; Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae; Community-Acquired Pneumonia due to Haemophilus influenzae, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae (TWAR); Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes; and Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare.
"This 1000 mg dosage form represents a formulation that offers the convenience of a single dose tablet versus Abbott's [the] currently available regimen of two tablets of 500 mg dosed on a once daily basis. This is the result of our innovative Research and Development Team and provides ease of administration to patients who might be prescribed this product," according to Dipak Chattaraj, President of Ranbaxy. Chattaraj added that "The FDA's approval clears the way for Ranbaxy to begin selling its innovative 1000 mg tablet, and Ranbaxy has already initiated the steps necessary for an expected product launch in May of this year. In late 2004, Ranbaxy initiated a Declaratory Judgement action against Abbott related to the Clarithromycin XL patents in the Northern District of Illinois."
Ranbaxy Pharmaceuticals Inc. ("RPI") based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited ("RLL"), 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 44 countries and manufacturing operations in 7 countries.
* Biaxin XL Filmtab(R) is a registered trademark of Abbott Laboratories
Ranbaxy Pharmaceuticals Inc.