HEALTH

Perrigo acquires rights to generic Delsym cough syrup

BY Michael Johnsen

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.

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McNeil Consumer Healthcare temporarily suspends operations in Pa. facility

BY Michael Johnsen

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.”

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FDA advisory committee to discuss curbing DXM abuse

BY Michael Johnsen

BETHESDA, Md. The Food and Drug Administration on Tuesday announced through the Federal Register that a Sept. 14 meeting will be held with its drug safety and risk management advisory committee to ascertain the abuse potential of the cough-cold ingredient dextromethorphan as part of the over-the-counter cough suppressant’s benefit/risk ratio.

The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for dextromethorphan in response to the increased incidence of abuse, especially among adolescents, the FDA reported.

It is not a fresh issue — the Consumer Healthcare Products Association has been raising awareness among parents around the potential of OTC and prescription-drug abuse among teens for several years. In addition, most if not all pharmacy retailers voluntarily require an age verification that a purchaser of DXM products be at least 18 years old at the point of sale.

According to survey data released in March by the Partnership for a Drug-Free America and MetLife Foundation, there was no significant increase in the abuse of over-the-counter cough medicines containing dextromethorphan. The 21st annual Partnership/MetLife Foundation Attitude Tracking Survey found that while lifetime abuse rates among teens for OTC cough medicines have remained relatively flat over the past few years, 12% of teens still report having abused an OTC cough medicine to get high at least once in their lives.

CHPA has been engaged in a long-term, comprehensive initiative to end this type of abuse with partners including the Partnership for a Drug-Free America, the Community Anti-Drug Coalitions of America, and D.A.R.E. America, and more recently, the National Association of School Nurses. 

“While these medicines [containing dextromethorphan] are safe and effective when used as directed, they can be dangerous when abused in extreme amounts, especially when combined with alcohol, illicit drugs or certain prescription drugs,” stated Linda Suydam, CHPA president. “The makers of OTC medicines have been aggressive in their efforts to prevent cough medicine abuse among teens.”

NASN and CHPA last month announced the launch of “Home to Homeroom,” an educational program that teams parents with the medical expert in their teen’s school — the school nurse — to help prevent and address teen medicine abuse.

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