Perrigo files for approval of generic nasal allergy drug
ALLEGAN, Mich. — Perrigo is seeking approval from the Food and Drug Administration for a drug used to treat allergies in adolescents and adults, the company said Monday.
Perrigo announced that it filed a regulatory application with the FDA for azelastine hydrochloride nasal spray in the 0.15% strength. The drug is a generic version of Meda Pharmaceuticals’ Astepro, used to treat nasal symptoms caused by seasonal allergies and environmental irritants in patients ages 12 years and older. Impax Labs has contributed to the filing as well, and both companies plan to share costs and benefits.
Meda filed suit against Perrigo last week in the U.S. District Court for the District of New Jersey in response to the filing, alleging patent infringement. The drug has sales of $114 million per year, according to Wolters Kluwer Health.
FDA panel gives thumbs down to Columbia Labs reproductive drug
PARSIPPANY, N.J. — A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug’s manufacturers said.
Columbia Labs and Watson Pharmaceuticals announced that the FDA’s Reproductive Health Drugs Advisory Committee did not recommend approval for progesterone vaginal gel in the 8% strength. The drug is designed to reduce the risk of preterm birth in women with short uterine cervical length in the middle trimester of pregnancy.
The FDA takes advisory committees’ recommendations into account when deciding whether to approve a drug, and while the recommendations are not binding, the agency doesn’t usually go against them. The FDA’s Division of Reproductive and Urologic Products is expected to take action on the drug by Feb. 26. Nevertheless, Columbia president and CEO Frank Condella said the company was confident that a late-stage clinical trial of the drug showed it to be safe and effective.
Shopko joins ranks with Rx mobile app
A mass merchandise retailer based in the Midwest has become the latest chain to join the move toward smartphone apps that allow customers to manage their pharmacy prescriptions. Fresh off the heels of its merger with Omaha, Neb.-based Pamida, Shopko announced the launch of an app for BlackBerry, Android and iPhone users that will allow customers to refill and manage their pharmacy prescriptions.
Customers using the app can request refills, review active prescription details — including expiration dates, refills remaining and overdue refills — set up dosage reminders, and receive email and text notifications when a refill is ready. It also includes a pharmacy locator that allows customers to locate and get driving directions to a pharmacy while checking hours of operation.
“We are always exploring new ways to improve customer service and make our pharmacy services more convenient, and this app makes finding our stores and filling prescriptions on their mobile devices quick and easy for our customers,” Shopko president, chairman and CEO Paul Jones said.
Several other retailers also have launched pharmacy apps recently. In October, Walgreens unveiled “Refill by Scan,” which allows patients to scan the bar code of a prescription and order refills in seconds, in addition to such previous technology as refill reminder text alerts and other apps for Apple, Android and BlackBerry devices. Meanwhile, supermarket chain Winn-Dixie launched a smartphone app and mobile website, m.WinnDixieRx.com. Customers can track their refill status and manage health information while locating Winn-Dixie pharmacies. An app for the Android and iPhone from CVS Caremark gives users access to the Drug Information Database and prescription management tools.