Perrigo gets tentative approval for generic Soolantra
The Food and Drug Administration has given its tentative approval to Perrigo’s generic Soolantra (ivermectin, 1%) cream. Perrigo said that it has previously settled litigation with Galderma Labs, Galderma SA and Nestle Skin Health for the product.
Perrigo’s generic Soolantra is indicated to treat inflammatory rosacea lesions. The product had U.S. sales of $120 million for the past 12 months, according to IQVIA data. This tentative approval is one in a string of FDA nods Perrigo’s products have received recently.
“This is the Rx team’s fifth generic product approval this month,” Perrigo executive vice president and president Rx pharmaceuticals John Wesolowski said. “This tentative approval further illustrates our commitment to advancing our new product pipeline and providing savings to patients and healthcare systems.”
Imprimis compounding 2 glaucoma drugs in short supply
Ophthalmology-focused company Imprimis Pharmaceuticals is dispensing alternatives to glaucoma treatments recently added to the Food and Drug Administration’s Drug Shortage List. The company has begun dispensing preservative-free dorzolamide and preservative-free dorzolamide/timolol — the latter of which is a compounded version of a combination marketed as Cosopt and Cosopt PF.
Imprimis said that the two medications were prescribed roughly 4 million in 2017, according to data from IQVIA. The compounded formulations it’s offering are free of the preservative benzalkonium chloride, or BAK, which is often found in glaucoma treatments. A 2013 Clinical Ophthalmology paper attributed such adverse effects as conjunctival inflammation and fibrosis, macular edema and anterior chamber inflammation, among others, to BAK.
“These effects can lead to ocular discomfort, poor intraocular pressure control, glaucoma surgery failure, and decreased patient compliance,” the paper noted.
Imprimis said the compounded products are currently available.
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.”