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Actavis (ACT) Denies FDA' Contraceptive Patch, Seeks More Data


12/27/2013 6:45:29 AM

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Actavis Receives Complete Response Letter from FDA For Progestin-Only Patch

DUBLIN
, Dec. 24, 2013 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the Company's subsidiary has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy.

The Company stated that it intends to work closely with the FDA to address the items raised in the complete response letter which primarily related to questions regarding the difference between the transdermal patch used in the clinical trial and the to-be-marketed transdermal patch, which represents a different size/formulation.

Data submitted to the FDA in support of approval of NDA for progestin-only patch included results from a 12-month, multicenter, open-label clinical trial conducted in the U.S., in accordance with FDA guidance for a contraceptive study. Actavis submitted the NDA to the FDA on February 26, 2013.

About Actavis

Actavis plc (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Actavis has global headquarters in Dublin, Ireland and U.S. administrative headquarters in Parsippany, New Jersey, USA.

Actavis markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries, and operates a global branded specialty pharmaceutical business focused in the Women's Health, Urology, Gastroenterology and Dermatology therapeutic categories. Actavis also has a portfolio of five biosimilar products in development in Women's Health and Oncology. Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, and includes Anda, Inc., a U.S. pharmaceutical product distributor.

For press release and other company information, visit Actavis' Web site at http://www.actavis.com.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Actavis' products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plc's Quarterly Report on Form 10-Q for the quarter ended September 30, 2013. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

CONTACTS:

Investors:


Lisa DeFrancesco


(862) 261-7152




Media:


Charlie Mayr


(862) 261-8030




David Belian


(862) 261-8141

(Logo: http://photos.prnewswire.com/prnh/20130124/NY47381LOGO)

SOURCE Actavis plc



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