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Monday, June 30, 2014

US FDA delays Allergan migraine drug approval, OKs new eye drug use, (NYSE: AGN), (NYSE: VRX), (TSE: VRX.TO)

Allergan Inc said on Monday that the U.S. Food and Drug Administration would not approve its acute migraine aerosol treatment until certain concerns are addressed, but the agency approved a new use for its implantable eye drug, Ozurdex.The Botox maker, which is fighting a hostile takeover bid by Valeant Pharmaceuticals International Inc, said Semprana, formerly known as Levadex, had received a second "complete response letter" from the FDA delaying its approval. Allergan now expects the agency's next action in the second quarter of 2015.Allergan shares were down 2.4 percent at $169.81.In its letter, the FDA expressed concern about the delivery device for the aerosol migraine medication, citing "content uniformity on the improved canister filling process and on standards for device actuation," Allergan said.

Allergan, Inc. is a multi-specialty health care Company focused on developing and commercializing pharmaceuticals, biologics, medical devices and over-the-counter products. Shares of AGN fell by 2.52% or $-4.38/share to $169.57. In the past year, the shares have traded as low as $82.56 and as high as $173.96. On average, 4527360 shares of AGN exchange hands on a given day and today's volume is recorded at 1669011.

Valeant Pharmaceuticals International, Inc., formerly Biovail Corporation, is a multinational, specialty pharmaceutical company that develops, manufactures and markets a range of pharmaceutical products. Shares of VRX fell by 1.78% or $-2.29/share to $126.56. In the past year, the shares have traded as low as $86.89 and as high as $153.10. On average, 3697400 shares of VRX exchange hands on a given day and today's volume is recorded at 1603026.

Valeant Pharmaceuticals International, Inc., formerly Biovail Corporation, is a multinational, specialty pharmaceutical company that develops, manufactures and markets a range of pharmaceutical products. Shares of VRX fell by 2.26% or $-3.12/share to $135.00. In the past year, the shares have traded as low as $89.35 and as high as $170.45. On average, 397017 shares of VRX.TO exchange hands on a given day and today's volume is recorded at 177141.



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