Ranbaxy First to Gain Approval to Manufacture and Market Clarithromycin for Oral Suspe... ( Ranbaxy One of Few Companies to Of...)

Ranbaxy First to Gain Approval to Manufacture and Market Clarithromycin for Oral Suspension, USP

Date:10/2/2007

Ranbaxy One of Few Companies to Offer Both Suspension and Tablet Forms

PRINCETON, N.J., Oct. 2 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Clarithromycin for Oral Suspension, USP, 125 mg/5 mL and 250 mg/5 mL. Ranbaxy is the first company to have been granted a generic approval for the Oral Suspension form along with Clarithromycin Tablets. Total annual market sales for Clarithromycin were $99.7 million with suspension sales totaling $25.3 million (IMS - MAT: June 2007).

"We are pleased to receive this FDA approval for Clarithromycin for Oral Suspension, an anti-infective agent that will add depth and breadth to our product line of anti-infectives that also includes Clarithromycin tablets. RPI will be in a position to offer both dosage forms for this molecule that will distinguish Ranbaxy in the market place. This approval further expands our product portfolio of affordable generic alternatives and will be shipped immediately to all classes of trade," according to Jim Meehan, Vice President of Sales and Distribution for RPI.

The Office of Generic Drugs, U.S. FDA, determined the Ranbaxy formulation to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Biaxin(R) Granules (Clarithromycin for Oral Suspension, USP), 125 mg/5 mL and 250 mg/5 mL of Abbott Laboratories.

Clarithromycin for oral suspension, USP, is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in a number of conditions including: Pharyngitis/Tonsillitis, Community-Acquired Pneumonia, uncomplicated skin and skin structure infections and disseminated mycobacterial infections.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly own
'/>"/>

0

GOOD

Page: 1 2
Related medicine news :

1. RANBAXY - enters anti-AIDS segment
2. Ranbaxy joins hand with Cipla to co-market ciprofloxacin
3. Ranbaxy gets US FDA approval for Lisinopril
4. Ranbaxy Labs Entry Into Anti-Acne Market
5. Ranbaxy trying to make inroads in herbal drugs market
6. Lamivudine Manufactured By Ranbaxy gets the nod from the US FDA
7. Ranbaxy Pharmaceuticals Inc awarded the prestigious outstanding supplier award received from Wal-Mart
8. Ranbaxy opens Drug discovery centre in Gurgaon
9. Ranbaxy Laboratories All Set To Export Bird Flu Vaccines
10. SRL Ranbaxy offers quicker bird flu diagnostic test
11. Diagnostic Test Launched by Ranbaxy for En Masse Screening of Bird Flu

Post Your Comments:

Ranbaxy First to Gain Approval to Manufacture and Market Clarithromycin for Oral Suspe...( Ranbaxy One of Few Companies to Of...),Health