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.”
Hyland’s teams up with Generation Rescue to raise autism awareness
LOS ANGELES Hyland’s on Monday announced its partnership with Generation Rescue to participate in the Pavilion of Exhibitors at this year’s AutismOne & Generation Rescue Conference: Autism Redefined — which will be held in Chicago from May 24 through 30.
“We are extremely honored to join forces with Generation Rescue at this year’s conference to support families with autism,” stated Thao Le, director of marketing at Hyland’s. “With 1-out-of-every-110 children affected by autism, we believe this is a cause that should increase in awareness.”
In addition to its presence at the Autism Redefined 2010 Conference, Hyland’s is sponsoring a month-long giveaway of five one-year My Gym Children’s Fitness Center memberships for special needs families. Many My Gym centers provide programs specifically designed to emphasize balance, fine and gross motor development, and coordination along with an opportunity to socialize with their peers. Entries must be received between by the end of May.
As part of the Generation Rescue Ballroom, Hyland’s will provide conference attendees with information on homeopathic medicines, offer Calms Forte 4 Kids samples, and hold a raffle for a Hyland’s Health Toolbox giveaway.