FDA approves Upsher-Smith’s generic Bumex
The Food and Drug Administration has approved Upsher-Smith’s generic Bumex (bumetanide) tablets. The drug is indicated to treat edema associated with congestive heart failure, hepatic disease and renal disease, including nephrotic syndrome.
Upsher-Smith’s generic Bumex is available in 0.5-, 1- and 2-mg dosage strengths, all of which are available in 100-count bottles. The company said it plans to launch the generic in February. The product had U.S. sales of $84.5 million for the 12 months ended November 2017, according to IQVIA data.
The approval follows a year that saw Upsher-Smith get acquired by Japan’s Sawai Pharmaceutical.
“Last year was an exciting one for Upsher-Smith,” president and CEO Rusty Field said. “We were part of one of the largest pharmaceutical transactions of the year and continued to expand our generic product portfolio. We are pleased to begin this year by adding bumetanide tablets to our portfolio of quality generic products.”
Cipla’s generic Viread approved by the FDA
The Food and Drug Administration has approved Cipla’s generic Viread (tenofovir disoproxil fumarate) tablets. Cipla said it would begin shipping the drug immediately.
The drug is indicated to treat patients ages 12 years and older with HIV-1 in combination with other antiretroviral agents. Cipla’s generic Viread will be available in 300-mg dosage strength. The product had U.S. sales of roughly $725 million for the 12 months ended November 2017, according to IQVIA data.
Perrigo’s generic Onexton Gel gets tentative FDA nod
The Food and Drug Administration has tentatively approved Perrigo’s generic Onexton Gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%). Perrigo said that it had previously settled litigation with Valeant Pharmaceuticals North America and Dow Pharmaceutical Sciences for the product.
“This tentative approval is another example of making long-term investments in our extended topicals strategy,” Perrigo executive vice president and president Rx pharmaceuticals John Wesolowski said. “The Rx team continues to invest in bringing important products to market that provide savings to patients and healthcare systems.”
Onexton Gel is indicated to treat acne vulgaris in patients ages 12 years and older. The product had branded sales of $115 million for the past 12 months, Perrigo said.