January 2020: Rx Products

LIDOCAINE OINTMENT, USP, 5%MANUFACTURED BY: SunGen Pharma

The FDA has approved a new drug application for SunGen Pharma's lidocaine ointment USP, 5%, indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also used as an anesthetic for intubation and for the temporary relief of pain associated with insect bites, minor burns, and skin abrasions. Lidocaine has annual sales of about $60 million.

FOR MORE INFORMATION: sungenpharm.com

TRIKAFTAMANUFACTURED BY: Vertex Pharmaceuticals Incorporated

The FDA has approved Vertex Pharmaceuticals Incorporated’s Trikafta (elexacaftor, ivacaftor, and tezacaftor), a breakthrough therapy for cystic fibrosis. It is the first triple combination therapy for patients 12 years and older with the most common cystic fibrosis mutation: the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene. This mutation is estimated to be the most common, present in 90% of the population that has cystic fibrosis. The most common adverse effects include diarrhea, headaches, and upper respiratory tract infection.

FOR MORE INFORMATION: trikafta.com

TALICIAMANUFACTURED BY: RedHill Biopharma Inc

RedHill Biopharma Inc has launched the new therapy Talicia (omeprazole magnesium, amoxicillin, and rifabutin) for the treatment of Helicobacter pylori infection in adults. The delayed-release capsules are available in omeprazole magnesium 10.0-mg, amoxicillin 250.0-mg, and rifabutin 12.5-mg strength. This is the only rifabutin-based therapy for the H pylori infection and is designed to address the increasing resistance of H pylori to clarithromycinbased therapies. Study findings of Talicia showed no resistance from H pylori compared with 17% resistance to the standard-of-care macrolide antibiotic.

FOR MORE INFORMATION: redhillbio.com

VUMERITYMANUFACTURED BY: Biogen

The FDA has approved Biogen’s Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis, including active secondary progressive disease, clinical isolated syndrome, and relapsingremitting disease. The drug is a novel oral fumarate with a distinct chemical structure, causing it to rapidly convert into monomethyl fumarate once in the body. In interim results from a phase 3 trial, the drug showed a low overall rate of discontinuation due to adverse events (AEs). The most common AEs include flushing, itching, nausea, rash, and redness.

FOR MORE INFORMATION: biogen.com