You are here

Generic Version of Zithromax Gains FDA Approval

SCHAUMBURG, Ill., Dec. 14 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (NASDAQ:APPX) , today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Azithromycin for Injection, the generic equivalent of Pfizer Inc.'s Zithromax(R). Sales of this product exceeded $69 million in 2004 and were more than $74 million through the first nine months of 2005, according to IMS. APP expects to commence marketing Azithromycin in the 2006 first quarter, with GPO contracts in place.

"The addition of Azithromycin expands our anti-infective portfolio to 18 products and extends to 11 the number of different classes of anti-infectives APP offers," said Patrick Soon-Shiong, M.D., chairman and chief executive officer. "Azithromycin is the sixth multi-source product approval APP has received this year."

Azithromycin will be available from APP in 500 mg vials. The product is preservative-free and AP rated and each vial will include a bar code and latex-free vial stopper.

Azithromycin for Injection is indicated for the treatment of community-acquired pneumonia and pelvic inflammatory disease, when caused by susceptible microorganisms.

Source: American Pharmaceutical Partners, Inc.

Recent Headlines

Medical Device Enables Nerve Stimulation During Sleep
May Offer Improved Safety Profile for Pediatric Patients
Hope for Sufferers With Post-Treatment Lyme Disease Syndrome
KardiaMobile Receives Two More Clearances for Arrhythmia Detection
Possible First Treatment Option for Rare Autoimmune Disease of the CNS
New Hematologic Biomarker Test Provides New Approach to Sepsis Triage and Diagnosis
Antibiotics, Statins, and Glucocorticoids All Show Promise
Current, Sole Therapy Not Always Successful/Suitable