Allergan (AGN) Gets FDA Nod For Avycaz Label Expansion

Allergan (NYSE:AGN_pa) plc (NYSE:AGN) announced that the FDA has expanded the label of its antibiotic, Avycaz. The label now includes phase III data on Avycaz plus metronidazole for the treatment of complicated intra-abdominal infections (cIAI) caused by designated susceptible microorganisms. The label has also been updated to include phase III data from a subset of patients with infections due to ceftazidime-nonsusceptible (CAZ-NS) pathogens, as well as a subset of patients who had pathogens producing certain extended-spectrum beta-lactamases (ESBLs).

Allergan, which is selling its generics business to Teva Pharmaceutical Industries Limited (NYSE:TEVA) for net cash/equity proceeds of about $36 billion, is working on expanding and strengthening its branded business. The company has more than 70 projects in mid-to-late stage development and is also working on expanding the labels of existing products.

Earlier this month, the FDA had accepted for review a supplemental New Drug Application (sNDA) for the 72 mcg dose of Linzess for use in the treatment of adults with chronic idiopathic constipation (CIC). A response from the agency should be out early next year.

Meanwhile, interesting pipeline candidates include abicipar (age related macular degeneration), rapastinel (depression), ubrogepant (migraine), XEN45 (glaucoma) and tavilermide (dry eye) among others.

Although the termination of the combination agreement with Pfizer, Inc. (NYSE:PFE) was disappointing, we remain optimistic about the stand-alone company’s growth prospects. We expect Allergan to continue pursuing tuck-in acquisitions and buying R&D assets.

Allergan is a Zacks Rank #3 (Hold) stock. Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) is a better-ranked stock in the healthcare sector with a Zacks Rank #1 (Strong Buy). Pfizer is also a Zacks Rank #1 stock.

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