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Actavis, Forest Laboratories receive request for additional information from FTC

BY Michael Johnsen

DUBLIN  — Actavis and Forest Laboratories on Thursday announced that they have each received a request for additional information from the Federal Trade Commission in connection with Actavis’ pending acquisition of Forest. 

The effect of the second request is to extend the waiting period until 30 days after Actavis and Forest have substantially complied with the request, unless that period is extended voluntarily by the parties or terminated sooner by the FTC.  

Actavis and Forest intend to cooperate fully with the FTC and they continue to expect the transaction to close in mid-year 2014.

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Actavis to acquire five products from Akorn/Hi-Tech Pharmacal

BY Michael Johnsen

DUBLIN — Actavis on Friday announced that it has entered into agreements with Akorn and Hi-Tech Pharmacal to purchase four currently marketed products and one product under development for cash consideration. The closing of the purchase agreements are contingent upon the consummation of Akorn’s acquisition of Hi-Tech. Financial terms of the agreements were not disclosed.

The agreements include three products marketed under abbreviated new drug applications — ciprofloxacin hydrochloride ophthalmic solution, levofloxacin ophthalmic solution and lidocaine hydrochloride jelly — and one product marketed under a new drug application: lidocaine/prilocaine topical cream.  

"The acquisition of these products will complement our expanding portfolio of topical and ophthalmic generic products, and further strengthen our position as a leader in developing and marketing the complex, high-barrier products that provide enhanced value," stated Siggi Olafsson, president of Actavis Pharma.

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FDA approves Merck’s ragweed allergy remedy Ragwitek

BY Michael Johnsen

WHITEHOUSE STATION, N.J. — Merck on Thursday announced that the Food and Drug Administration has approved Ragwitek (short ragweed pollen allergen extract) tablet for sublingual use (12 Amb a 1-U). Ragwitek is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis. Ragwitek is approved for use in adults ages 18 years through 65 years. 

"Ragwitek provides a new sublingual approach to allergen immunotherapy for adult patients suffering from moderate to severe ragweed pollen allergies who have declined allergy shots," said David Skoner, director of the division of allergy and immunology for Allegheny Health Network and a clinical investigator in Merck’s sublingual allergen immunotherapy tablet program. "While there are regional variations, ragweed season typically starts in mid-August across the United States. During the season, many patients with moderate to severe allergic rhinitis experience nasal and ocular allergy symptoms at their worst while taking symptom-relieving medication. These patients often have multiple sensitivities. To help prepare for the upcoming ragweed season, I would encourage patients diagnosed with ragweed pollen allergies to make an appointment now with an allergy specialist to discuss options."

Ragwitek is not indicated for the immediate relief of allergic symptoms.

Ragwitek is contraindicated in patients with severe, unstable or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.

Symptoms of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis may include sneezing; a runny or itchy nose; stuffy or congested nose; or itchy and watery eyes, and typically intensify during the ragweed pollen season.

Ragwitek will be available in U.S. pharmacies by the end of April.

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