PHARMACY

Bydureon officially hits market

BY Allison Cerra

SAN DIEGO — Amylin Pharmaceuticals and Alkermes announced that their Type 2 diabetes treatment now is available by prescription in U.S. pharmacies.

Bydureon (exenatide extended-release for injectable suspension) received approval from the Food and Drug Administration on Jan. 27 as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

In line with the official launch, the drug makers said eligible patients will have access to the Bydureon Steady Savings Card to help offset co-pay costs by saving up to $50 per month for up to 24 months. Details about the program can be found here.

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PHARMACY

Columbia Labs transfers NDA for reproductive drug to Watson

BY Allison Cerra

LIVINGSTON, N.J. and PARSIPPANY, N.J. — Columbia Labs has transferred a new drug application for a topical drug designed to prevent premature birth in pregnant women to Watson Pharmaceuticals.

Columbia Labs said Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to the application for progesterone vaginal gel 8%. Late last month, the drug received a thumbs-down from an FDA panel that declined to recommend approval for it.

The FDA is expected to take action on the NDA by Feb. 26.

"We continue to enjoy a strong working relationship with Watson, and believe this is the appropriate time to transfer the NDA," Columbia Labs president and CEO Frank Condella said. "As a result of this action, shareholders and other stakeholders can be assured that Watson will provide the resources available, as a result of its position as a $4.6 billion global pharmaceutical industry leader, to support continued progress of this application."

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Watson confirms Beyaz patent challenge

BY Allison Cerra

PARSIPPANY, N.J. — A subsidiary of Watson Pharmaceuticals is seeking approval for its version of an oral contraceptive from the Food and Drug Administration.

Watson Labs has filed an abbreviated new drug application with the FDA and is seeing to market drospirenone and ethinyl estradiol and levomefolate calcium tablets in the 3-mg/0.02-mg/0.451-mg strength and levomefolate calcium tablets in the 0.451-mg strength, a generic version of Bayer HealthCare Pharmaceuticals’ Beyaz.

In related news, Watson also confirmed that Bayer, along with Bayer Pharma AG, and Merck & Cie filed suit against Watson on Feb. 10 in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing the product prior to the expiration of U.S. patent No. 6,441,168. The drug maker said it believes it may be a a "first applicant" to file an ANDA for the generic version of Beyaz and may be entitled to 180 days of generic market exclusivity (should its ANDA be approved).

Beyaz had total U.S. sales of approximately $97 million for the 12 months ended Dec. 31, 2011, according to IMS Health data.


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