ACETO Debuts Generic, BioCryst Sees IND Put On Hold: Healthcare Business Recap
In a Tuesday press release, ACETO Corporation (NASDAQ:ACET) reported that Rising Pharmaceuticals, its finished dosage form generics unit, introduced the generic version of the 75mg/*5mL strength of Clindamycin Palmitate Hydrochloride for Oral Solution, USP (Pediatric), which is an FDA-approved generic version of Pfizer ‘s (NYSE:PFE) Cleocin Pediatric. Domestic market sales for Clindamycin Palmitate Hydrochloride, an antibiotic employed to treat serious infections caused by bacteria, stood at about $59 million for the twelve months ended June 30th, according to IMS Health data. ACETO is a worldwide leader in the marketing, sale and distribution of products for pharmaceutical ingredients, human health, and performance chemicals.
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Perrigo Company (PRGO) announced Tuesday in a release that its partner, Cobrek Pharmaceuticals, has received final FDA approval for its Abbreviated New Drug Application for betamethasone valerate foam 0.12 percent, which represents the generic equivalent of Luxiq Foam. Perrigo has manufactured the product and is set to start commercial shipments on January 15th.
On Tuesday a week ago, BioCryst Pharmaceuticals (NASDAQ:BCRX) was notified by the FDA that the Investigational New Drug (NYSE:IND) application for BCX4161 has been placed on clinical hold, as the agency is applying GMP manufacturing standards to the process of compounding BCX4161 capsules at the clinical site to be used for oral dosing studies. However, it should be noted that the practice of compounding drug product at clinical sites is fairly common in Phase 1 studies.
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