FDA approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people aged 18 and older.
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:
•
Akorn
•
Aurobindo Pharma
•
Dr. Reddy’s Laboratories
•
Glenmark Generics
•
Hi-Tech Pharmacal
•
Lupin
•
Mylan
•
Sagent Strides
•
Sandoz
•
Teva
•
Torrent Pharmaceuticals
•
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.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.