FDA approves Amerigen’s generic cyclophosphamide
The Food and Drug Administration has approved Amerigen Pharmaceuticals’ abbreviated new drug application for two dosage strengths of its cyclophosphamide capsules. The drug, a generic of West-Ward’s product, is an anti-neoplastic agent indicated to treat various cancers.
Amerigen’s generic cyclophosphamide will be available in 25- and 50-mg capsules. The company said it plans to launch the drug soon, manufactured by Irvine Pharmaceuticals.
FDA approval spurs launch of Lupin’s generic Clobex Spray
The same week Lupin received approval from the Food and Drug Administration for its generic Clobex Spray (clobetasol propionate spray, 0.05%), the company launched the drug.
Baltimore-based Lupin’s generic Clobex Spray is a treatment for moderate-to-severe plaque psoriasis that affects up to 20% body surface area in patients ages 18 years old and older.
The product had a market size of roughly $30.5 million for the 12 months ended January 2018, according to IQVIA data.
Sandoz launches its Aloxi generic
Sandoz has introduced its Aloxi generic (palonosetron hydrochloride injection). The drug is indicated to help prevent nausea and vomiting associated with chemotherapy in adults and children ages one month old to less than 17 years old.
“Chemotherapy-induced nausea and vomiting can often add unnecessary hardship to cancer treatment – exacerbating an already sensitive and emotional time for cancer patients,” Sandoz president Carol Lynch said. “That is why it is important for Sandoz to provide patients with a high-quality and accessible generic version of this medicine in the United States.”
Sandoz’s Aloxi generic will be marketed in single-dose vials in 0.25 mg/ml dosage strength. The product had U.S. sales of roughly $447 million for the 12 months ended January 2018, according to IQVIA data.