Sagent Pharmaceuticals Announces U.S. FDA Approval Of Azithromycin For Injection

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 27 Mar 2009 - 3:00 PDT

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Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, 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.

About Azithromycin

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.

About Sagent Pharmaceuticals, Inc.

Sagent Pharmaceuticals, founded in 2006, is a privately held specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products. Sagent has created a unique, global network of resources, comprised of rapid development capabilities, sophisticated manufacturing and innovative drug-delivery technologies, quickly yielding an extensive portfolio of pharmaceutical products that fulfills the evolving needs of patients. Sagent currently has more than 200 products in development.

To Discover Injectables Excellence(TM) and learn more about Sagent, please visit http://www.SagentPharma.com.

About Strides Arcolab, Ltd.

Strides, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a Bangalore, India headquartered global pharmaceutical company. Strides manufactures pharmaceutical formulations in various dosage forms including sterile injectables with dedicated facilities for penicillin and penems, cephalosporins, oncolytics and lyophilized injectable products. The company also manufactures pharmaceutical formulations in oral dosage forms, including capsules and tablets and Softgel capsules. Strides operates in and has significant presence in Australasia, Africa and India and through a series of strategies is expanding its North American and European growth. The company has a series of joint ventures and front-ended operations in major markets and is a majority stakeholder of Ascent Pharmahealth Limited (APH), an ASX listed company. The company also collaborates closely with Global Drug Agencies and US PEPEFAR and the UNICEF to supply a range of affordable generic pharmaceutical products used in the treatment of HIV, TB and malaria.

Strides has manufacturing facilities in Bangalore, India and overseas facilities in Milan, Warsaw, Singapore and Lagos. The Indian manufacturing facilities are approved by all major regulatory bodies. Strides employs approximately 2,500 people across the globe. Strides also has a marketing presence in over 50 countries.

Additional information is available at the company's website at http://www.stridesarco.com.

Sagent Pharmaceuticals, Inc.
http://www.SagentPharma.com

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