Celeboxib Generics Hit Market, New Drug to Treat MRSA Approved, and More
The FDA has approved the generic versions of Celebrex (celecoxib) capsules, to be used for the treatment of rheumatoid arthritis, osteoarthritis, short-term acute pain, and other conditions.
The generic capsules can be marketed in 50 mg, 100 mg, 200 mg, and 400 mg doses.
Note: Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs.
The most commonly reported side effects to Celebrex include abdominal pain, diarrhea, indigestion, flatulence, swelling of the feet and legs, accidental injury, dizziness, inflammation of the throat, runny nose, swollen nasal passages, upper respiratory tract infection, and rash.
Reference:
FDA. FDA approves first generic versions of celecoxib [press release]. May 30, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm399428.htm. Accessed June 5, 2014.
The FDA has approved Dalvance (dalbavancin), a new antibacterial drug to treat adults with skin infections.
Dalvance is an intravenous treatment for acute bacterial skin and skin structure infections caused by bacteria, such as Staphyloccoccus aureus (methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes.
It is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. It was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections.
The QIDP designation gives Dalvance priority review and qualifies the drug for an additional 5 years of marketing exclusivity.
The most common side effects include nausea, headaches, and diarrhea. In the trial study, more participants in the Dalvance group reported elevations in 1 of their liver enzyme tests.
Reference:
FDA. FDA approves Dalvance to treat skin infections [press release]. May 23, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398724.htm. Accessed June 5, 2014.
A new FDA-approved test can help determine if a specific type of kidney disease—membranous glomerulonephritis (MGN)—is due to the body’s rejection of its own kidney tissue or due to another cause.
MGN is a chronic kidney disease that causes damage to blood vessels in the kidney that filter blood and remove waste and excess fluid. While some cases of MGN are associated with secondary conditions (eg, infections, tumors, adverse reactions to drugs, or poisoning), 85% of cases are caused by the body’s immune system mistakenly attacking healthy kidney tissue—a condition called primary MGN (pMGN).
The EUROIMMUN Anti-PLA2R IFA blood test can help detect if a patient has an antibody that is specific to pMGN. Treatment can then be determined based on the cause.
In a clinical study of 560 blood samples, the test was able to detect pMGN in 77% of pMGN samples and a false positive in less than 1% of other disease samples.
The FDA notes that the test should not used alone to diagnose pMGN nor should it be used to monitor the stage of the disease or response to treatment.
Reference:
FDA. FDA allows marketing of first non-invasive test to help in identifying cause of cetain kidney disease [press release]. May 29, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm399327.htm. Accessed June 5, 2014.