Perrigo acquires rights to generic Delsym cough syrup
ALLEGAN, Mich. Perrigo on Wednesday announced that it has acquired the exclusive U.S. store brand rights to sell and distribute dextromethorphan polistirex extended-release suspension cough suppressant — the generic version of Reckitt Benckiser’s Delsym — from Tris Pharma.
Tris believes it has a first-to-file ANDA application for the generic that can entitle it to 180 days of generic exclusivity upon approval. Tris and Reckitt Benckiser are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Tris ANDA filing. Under the agreement Perrigo and Tris will share profits, and Perrigo will pay Tris certain milestone payments.
Delsym had annual sales of approximately $125 million dollars, Perrigo reported, citing SymphonyIRI data.
McNeil Consumer Healthcare temporarily suspends operations in Pa. facility
FORT WASHINGTON, Pa. In a statement released Tuesday, McNeil Consumer Healthcare stated: “The quality issues that [the Food and Drug Administration] has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate.”
McNeil Consumer Healthcare last week voluntarily recalled all lots that have not yet expired of certain over-the-counter children’s and infants’ liquid products in consultation with the Food and Drug Administration. The agency suggested that McNeil’s Fort Washington, Pa. plant may not be compliant with Good Manufacturing Practices.
“Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles,” the FDA stated on its Web site.
Both the FDA and McNeil suggested the risk for adverse events associated with the recalled products was relatively low.
Following the recall, McNeil has temporarily suspended production at its Fort Washington production facility. “We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there,” McNeil stated. “We will continue to work in close consultation with the FDA to take corrective action and ensure that our quality operations meet the high standards that consumers expect from us.”
APhA survey: Pharmacists recommend over-the-counter products to consumers
WASHINGTON Pharmacists believe that 82% of consumers purchase over-the-counter products that actually were recommended to them by a pharmacist, according to the most recent “Pharmacy Today Over-the-Counter Product” survey conducted by the American Pharmacists Association.
The survey, completed by more than 1,000 APhA member and nonmember pharmacists, also found that pharmacists counsel 29 patients on average per week around the use of nonprescription medicines. Patients who seek their pharmacist’s advice include patients requiring assistance in identifying the most appropriate product (90%), patients that are worried about using an OTC product with other prescription medications (80%), patients suffering from an acute or chronic condition (79%), and patients worried about taking OTC products with a specific disease/condition (65%).
“Pharmacists are the medication experts on the healthcare team,” stated Thomas Menighan, APhA CEO. “[They] are trained not only about prescription medications, but also nonprescription medications, supplements and herbals.”
One of APhA’s goals in conducting the annual “Pharmacy Today Over-the-Counter Product” survey is to educate consumers that pharmacists have the knowledge and training to help them select the right OTC medications. As part of the survey, pharmacists are asked to tabulate the OTC products they recommend per week in 76 different product categories.
As part of the survey, pharmacists were asked how many times per week they had recommended each product. Those brands that indexed higher than 60% among pharmacist recommendations included: Procter & Gamble’s Crest Whitestrips (87%); GlaxoSmithKline’s Breathe Right (74%); Amerifit Brands’ AZO Test Strips (UTI test) (72%); Church & Dwight’s First Response (ovulation test kits) (70%); McNeil Consumer’s Sudafed (70%); Omron blood pressure monitors (70%); Reckit Benckiser’s Mucinex family of products (63%).