Sagent Pharmaceuticals receives FDA approval of Azithromycin for injection

Mar 26 2009

Sagent Pharmaceuticals, Inc. has announced U.S. Food and Drug Administration (FDA) approval of azithromycin for injection, a semi-synthetic, macrolide antibiotic that is used to treat a wide variety of bacterial infections. Sagent will offer azithromycin in a 500 mg vial for intravenous use.

The Company anticipates the launch of azithromycin in April 2009. According to IMS, 2008 sales of azithromycin in the United States approximated $42 million.

"This approval marks an important milestone for Sagent, as azithromycin is the first product from our joint venture - established in 2007 - with Strides Arcolab," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. "Strides' manufacturing and development expertise will be invaluable as we move forward with not only azithromycin, one of the world's most widely used antibiotics, but also with the more than 25 products under development by the joint venture."

Under the joint venture agreement, Sagent and Strides Arcolab are developing, supplying and marketing more than 25 injectable products for the U.S. market. Strides is responsible for developing and supplying injectable products that Sagent will market in the United States.

Since late 2007, Sagent launched eight products and currently has more than 70 Abbreviated New Drug Applications (ANDA) submissions on file with the U.S. FDA.

Azithromycin for injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the following conditions: community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy and pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin for injection. Sagent's azithromycin is the generic equivalent of Pfizer's Zithromax(R).

Most common side effects are gastrointestinal including diarrhea, nausea, abdominal pain and vomiting. Serious allergic reactions, nervousness, dermatologic reactions, and fatalities have been reported but are extremely rare.