|July 25, 2014|
|07:33 EDT||AGN||EMA recommends expanded indication for Ozurdex|
The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Ozurdex from Allergan Pharmaceuticals Ireland. The CHMP adopted a new indication as follows: "Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular edema who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy."
News For AGN From The Last 14 Days
|August 31, 2015|
|08:04 EDT||AGN||Allergan completes Nuarex acquisition|
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|07:39 EDT||AGN||Citi calls Allergan a 'stock to own,' keeps $360 target|
Citi analyst Liav Abraham calls Allergan a "stock to own" given its "attractive" organic growth profile, pipeline potential and ability to do more acquisitions. He reiterates a Buy rating on the stock with a $360 price target.
|August 28, 2015|
|09:50 EDT||AGN||Allergan plans for generic version of Endo's Fortesta blocked, Bloomberg reports|
A judge upheld Endo's (ENDP) patents on Fortesta expiring in 2018 and blocked Allergan's (AGN) bid to launch a generic version of the testosterone gel, according to Bloomberg.
|August 25, 2015|
|08:14 EDT||AGN||Allergan multiple is low, says Leerink|
Leerink predicts that Allergan's 2016 EPS will come in at $17-$18. The firm thinks the company has "durable revenue streams," and a "deep pipeline with several potential blockbuster candidates." Leerink adds that the company "has significant capacity for M&A." It keeps a $388 price target and Outperform rating on the shares.
|August 24, 2015|
|08:37 EDT||AGN||Allergan recalls certain lots of REFRESH, FML, Blephamide treatments|
Allergan announced that it is conducting a voluntary recall down to consumer level of specific lots of its REFRESH Lacri-Lube 3.5g and 7g for dry eye, REFRESH P.M. 3.5g for dry eye, FML 0.1%, and Blephamide 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g. Allergan chose to initiate this recall based on a small number of customer complaints which reported a small black particle at the time of use. Allergan has informed the U.S. Food and Drug Administration of this voluntary recall. Allergan is contacting retailers and wholesalers who have been shipped affected product lots to initiate the recall and is informing them of the steps needed to return affected product.
|August 20, 2015|
|08:16 EDT||AGN||Allergan's Botox resubmission for lower limb spasticiy accepted by FDA|
Allergan 's resubmission of its Supplemental Biologics License Application for Botox for the treatment of adults with lower limb spasticity in adults has been accepted by the FDA. A six-month review period has been assigned for the sBLA. The Prescription Drug User Fee Act date is expected to be in 1Q16. The resubmission provides additional data from a double-blind, placebo controlled study involving 468 patients with lower limb spasticity. The FDA also approved an increase to the maximum Botox cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.