FDA approves generic Levaquin

FDA approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people aged 18 and older.

Generic tablet, oral solution, and injectable solution dosage forms of levofloxacin have been approved. The following 12 manufacturer’s applications for generic levofloxacin have been approved:

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Akorn

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Aurobindo Pharma

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Dr. Reddy’s Laboratories

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Glenmark Generics

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Hi-Tech Pharmacal

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Lupin

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Mylan

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Sagent Strides

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Sandoz

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Teva

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Torrent Pharmaceuticals

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Wockhardt

“This approval provides generic versions of an important class of antibiotics [fluoroquinolones],” said David Belian, spokesperson for the Generic Pharmaceutical Association in Washington, DC. “Levofloxacin injection is used to treat infections such as pneumonia; chronic bronchitis; and sinus, urinary tract, kidney, prostate [a male reproductive gland], and skin infections.

“Levofloxacin injection is also used to prevent anthrax [a serious infection that may be spread on purpose as part of a bioterror attack] in people who may have been exposed to anthrax germs in the air,” added Belian. “Generic versions of this drug provide redundancy in the supply, which could be critical in a bioterror situation.”

All fluoroquinolones have a boxed warning alerting prescribers and patients that these products are associated with an increased risk of tendinitis and tendon rupture. The risk is greater in older people, especially in those older than aged 60, in patients taking corticosteroid drugs, and in those with kidney, heart, or lung transplants. The boxed warning also contains an alert that the drug may worsen muscle weakness in people with myasthenia gravis, a chronic autoimmune neuromuscular disease.

Levofloxacin must be dispensed with a patient Medication Guide that describes the drug’s uses and warnings.