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Actavis' Botox Upper Limb Spasticity Label Expanded by FDA - Analyst Blog

Actavis plcACT received positive news on the regulatory front with the FDA expanded Botox's label for the treatment of adults with upper limb spasticity to include two thumb muscles (flexor pollicis longus and adductor pollicis) as well as an increase in the maximum dose of the drug from 360 to 400 units. An increase in the cumulative dose (360 to 400 units) has also been approved for a period of three months for the treatment of adults with one or more indications.

Botox is the first and only FDA-approved neurotoxin for the treatment of upper limb spasticity. According to the company press release, more than 1.8 million Americans experience upper limb spasticity, which can occur anytime after they have suffered a stroke.

Botox is also approved for several other indications including cervical dystonia, chronic migraine, overactive bladder and strabismus.

Botox became a part of Actavis' portfolio following its acquisition of Allergan last month. Apart from Botox other renowned brands that have been acquired following the Allergan acquisition include Restasis, Latisse, Natrelle and Juvederm. With the Allergan acquisition, Actavis has become one of the top 10 pharmaceutical companies across the world based on sales. The company expects combined pro forma revenues to cross $23 billion in 2015.

Actavis has been pretty active on the acquisition front and has worked hard to strengthen its branded product portfolio. The Forest and Durata acquisitions have helped the company enhance its branded product portfolio and infectious disease portfolio, respectively.

Actavis is a Zacks Rank #2 (Buy) stock. Other favorably-placed stocks in the health care sector include CorMedix, Inc. CRMD , AVEO Pharmaceuticals, Inc. AVEO and Biogen Inc. BIIB . All three stocks sport a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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