IVAX Gets Final Approval For Doxycycline Hyclate Tablets
DOW JONES NEWSWIRES
May 13, 2005 12:07 p.m.
MIAMI -- IVAX Corp. (IVX) received final approval from the U.S. Food and Drug Administration for a generic equivalent of CollaGenex Pharmaceuticals Inc.'s (CGPI) Periostat tablets, used to treat bacterial infections and adult periodontitis.
In a press release Friday, IVAX said its pharmaceutical unit will sell a generic form of the doxycycline hyclate 20 mg tablets.
U.S. sales of Periostat tablets and doxycycline hyclate 20 mg tablets were $51 million during 2004, according to IMS data.
In 2004, IVAX had total revenue of $1.84 billion.
American Stock Exchange-listed shares of IVAX recently changed hands Friday at $18.41, down 17 cents, or 0.9% in composite trading, while CollaGenex Pharmacuetical shares traded at $4.10, down 11 cents, or 2.6%, in Nasdaq composite trading.
Separately Friday, IVAX received final marketing authorization from the Medicine and Healthcare Products Regulatory Agency for the generic equivalent of GlaxoSmithKline PLC's Flixonase nasal spray, used to treat rhinitis, also known as hay fever.
IVAX' fluticasone product has been developed for the UK by IVAX Research Inc. and is part of a worldwide development program.
The company said this is the first generic approval for fluticasone in the UK and IVAX will be marketing the product immediately.
Annual UK sales of Flixonase are about $30 million. IVAX expects to pursue further approvals for the product across Europe, and has an Abbreviated New Drug Application for a generic equivalent of Flonase pending with the U.S. Food and Drug Administration.
Company Web site: ivax.com |
