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Mylan can launch authorized generic Parkinson’s drug under settlement

BY Alaric DeArment

PITTSBURGH — Mylan and Orion Corp. have settled a patent-infringement suit over a drug used to treat Parkinson’s disease, Mylan said Thursday.

The generic drug maker had filed with the Food and Drug Administration for a generic version of Orion’s Stalevo (carpidopa; levodopa; entacapone) tablets, used to treat idiopathic Parkinson’s to substitute for immediate-release carbidopa/levodopa and entacapone administered separately.

Under the agreement, Mylan can immediately launch an authorized generic version of Stalevo and then launch its own generic after the FDA approves it. An authorized generic is the original branded drug marketed under its generic name at a discount, usually through a third-party company. Mylan is seeking approval for the drug in the 12.5-mg/50-mg/200-mg, 18.75-mg/75-mg/200-mg, 25-mg/100-mg/200-mg, 31.25-mg/125-mg/200-mg, 37.5-mg/150-mg/200-mg and 50-mg/200-mg/200-mg strengths.

Stalevo had sales of about $138.6 million during the 12-month period that ended in March, according to IMS Health.


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Kmart launches Pay in Store

BY Alaric DeArment

HOFFMAN ESTATES, Ill. — Kmart is letting customers reserve items online and then pay for it and pick it up at the store, the mass merchandise retailer said.

The chain, a subsidiary of Sears Holdings, said the nationwide launch of Pay in Store for members of the Shop Your Way loyalty program marked a first in the company’s "integrated retailing" program, calling it an example of how it is evolving to provide a seamless and integrated shopping experience for members, whether they shop online, through mobile or at the store.

"With Pay in Store, we offer our members more choices and provide access to online shopping for a large, underserved portion of the U.S. population that wants the convenience of shopping online but does not have a credit card or is reluctant to submit their card information via the Internet," Sears Holdings EVP and president for marketing, online and financial services Imran Jooma said. "We are addressing a need in a way no other large retailer is doing by giving members and customers ultimate flexibility, convenience and choice in how they shop and pay and the satisfaction of walking out minutes later with their items in hand."

With the program, customers ordering through Kmart.com can choose the Pay in Store option to reserve items for 48 hours and then head to the store after receiving a confirmation email. They then present their email confirmation, order number or phone number at the cash register and pay through credit card, debit card, gift card, points, cash or check.


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FDA grants exclusivity to Teva’s Plan B contraceptive

BY DSN STAFF

WASHINGTON — The Food and Drug Administration has granted the manufacturer of Plan B One-Step exclusive marketing rights for three years, according to published reports.

According to the New York Times, the decision by the FDA sets Teva Pharmaceuticals as the only company able to sell the drug over-the-counter and without a prescription to a person of any age.

Generic versions of the pill are subject to regulatory approval from the FDA for permission to be sold on OTC shelves rather than from a pharmacy counter, but approval of the generic version does not allow the manufacturer to sell the drug to anyone under 17 until the three year exclusivity period ends.

In April, a District Court judge in New York ruled the FDA had 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages allowing the drug to finally make its way to store shelves.

 

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