FDA approves Glenmark’s Clobex Spray generic
Glenmark Pharmaceuticals has received Food and Drug Administration approval for its generic Clobex Spray (clobetasol propionate spray, 0.05%). The drug is a corticosteroid indicated to treat moderate-to-severe plaque psoriasis in patients 18 years old and older.
Glenmark said that it will manufacture its Clobex Spray generic at its Baddi plant in India. The drug’s market saw sales of roughly $30.5 million for the 12 months ended January 2018, based on IQVIA sales data.
Generic Aloxi launches from Dr. Reddy’s
Dr. Reddy’s Laboratories has introduced its generic Aloxi (palonosetron hydrochloride injection). The drug, which had been previously approved by the Food and Drug Administration, is indicated to treat chemotherapy-induced nausea and vomiting in adults.
Dr. Reddy’s generic Aloxi will be available in 0.25 mg/5 ml dosage strength. It will be packaged in a carton containing one single-dose vial. The drug’s market size is roughly $446 million for the 12 months ended January 2018, according to IQVIA data.
Teva launches Lialda generic
Teva has introduced its Lialda generic (mesalamine delayed-release tablets). The drug is indicated to treat mild-to-moderate ulcerative colitis.
“The launch of mesalamine is a significant addition to Teva’s generic portfolio,” Teva executive vice president and head of North American Commercial Brendan O’Grady said. “With more than a million people in the U.S. estimated to suffer from inflammatory bowel diseases, including ulcerative colitis, this is an important and more affordable generic treatment option for our customers.”
Teva’s Lialda generic will be available in 1.2-g dosage strength. The product’s market size was roughly $1.11 billion for the 12 months ended January 2018, according to IQVIA data.