FDA approves generic forms of ciprofloxacin

Jun 14, 2004 (CIDRAP News) The Food and Drug Administration (FDA) last week approved the first generic versions of ciprofloxacin (Cipro), the antibiotic that drew national attention when it was used after the mail-borne anthrax attacks in 2001.

Thirteen generic versions of ciprofloxacin, also called cipro, won approval Jun 9, according to Jason Brodsky, a spokesman in the FDA commissioner's office. The approvals followed the recent expiration of Bayer AG's exclusive right to distribute the drug, he said.

Brodsky said the manufacturers of the generics are Barr Laboratories, Mylan Pharmaceuticals, Dr. Reddy's Laboratories, Ranbaxy Laboratories, Genpharm Inc., Sandoz, IVAX Pharmaceuticals, Carlsbad, Teva Pharmaceutical Industries, Hikma Pharmaceuticals, Martec Pharmaceutical, Eon Labs, and Cobalt Pharmaceuticals.

Barr Laboratories began marketing a version of ciprofloxacin under its own label in 2003, but the product was made by and sold under an agreement with Bayer, according to a Barr statement published last September.

The Barr statement said overall sales of ciprofloxacin totaled about $1.1 billion in the 12 months that ended in July 2003.

Thousands of postal workers took ciprofloxacin at the recommendation of federal health officials after someone mailed envelopes containing anthrax spores to several government and media offices in the fall of 2001. The attacks caused 22 illnesses, five of them fatal.