Having just won a court case concerning the risks of taking Levaquin, Johnson & Johnson will now have to compete with a number of generics of its big-selling antibiotic in the USA.
The US Food and Drug Administration has approved the first generic versions of Levaquin (levofloxacin), used to treat bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific germs. It also is used to treat certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax.
Oral and injectable forms of levofloxacin have been approved from 12 manufacturers - Akorn, Aurobindo, Dr Reddy's, Glenmark, Hi-Tech Pharmacal, Lupin, Mylan, Sagent Strides, Sandoz, Teva, Torrent and Wockhardt. First-quarter sales of Levaquin climbed 16.3% to $422 million, a figure that is going to take a battering in the quarters to come.
News of the generic approvals came just after a jury in Minneapolis, USA, decided that J&J was not responsible for an elderly man's ruptured Achilles tendon and had properly warned of the risks posed by taking Levaquin.
In July 2008, the FDA notified the manufacturers of fluoroquinolone drugs such as Levaquin and Bayer's Cipro (ciprofloxacin) that a black box warning about the risk of tendon ruptures and tendonitis were required. The warning particularly highlights the possible problem in people aged 60 who are taking corticosteroids, and in those with kidney, heart, or lung transplants.
It is the second of more than 2,500 pending claims and J&J lost the first trial when a jury awarded $1.8 million to a man who had ruptured both Achilles tendons.