FDA raises questions about Schering-Plough’s application for Zegerid
SAN DIEGO Santarus on Tuesday announced that Schering-Plough HealthCare Products recently received a Complete Response Letter from the Food and Drug Administration with questions on the proposed switch of Santarus’ prescription proton-pump inhibitor Zegerid.
Santarus is in regular communication with Schering-Plough, the specialty pharmaceutical company said, adding that Schering-Plough intends to continue to work closely with the FDA on a confidential basis to expeditiously address these questions and secure approval of OTC Zegerid.
The NDA for OTC Zegerid was submitted by Schering-Plough in March 2008. Schering-Plough licensed the OTC rights of Zegerid from Santarus in 2006.
Home Diagnostics reports revenue loss, gain in retail sales
FORT LAUDERDALE, Fla. Home Diagnostics, Inc. on Thursday posted total revenue of $24.6 million for the first quarter ended March 31, representing a decrease of 2.1%.
However, retail channel sales were up 25.2%, driven by the continued nationwide rollout of the TRUEresult and TRUE2go blood glucose monitoring systems and the rollout of TRUEtrack at Walmart, HDI stated.
“Our first quarter results are slightly better than our guidance,” stated Joseph Capper, HDI president and CEO. “While we are not satisfied with our current results, we are weathering the economic downturn substantially better than several of the larger branded companies in the industry, who reported double digit revenue declines in the first quarter. We view this as an indicator of the strength of our value offering, especially given the challenging economic environment, which we believe is driving patients to lower cost alternatives.”
In March 2009, the company received 510(k) clearance from the Food and Drug Administration for TRUEbalance, the company’s new low-cost, no-coding meter. TRUEbalance broadens the company’s no-code product portfolio to meet the specific needs of certain segments of the market. HDI anticipates launching TRUEbalance in the second quarter of 2009.
Insight Pharmaceuticals acquires Church & Dwight OTC products
LANGHORNE, Pa. Insight Pharmaceuticals on Wednesday announced the acquisition of seven brands from Church & Dwight, including Auro-Dri, an ear-drying aid; Boil Ease, a boil pain-relief product; Dermarest eczema treatment; the Gentle Naturals line of baby care products; lice treatment brand Pronto Plus; the liquid bandage Skin Shield; and the eye ointment Stye.
Financial terms were not disclosed.
The addition of the Church & Dwight brands to the Insight portfolio will strengthen its position in the OTC pharmaceuticals arena, Insight stated.