Impax Laboratories, Inc.‘s (IPXL) branded products division, Impax Pharmaceuticals, announced that the FDA has extended the review date for the company’s New Drug Application (:NDA) for Rytary (IPX066) by three months. The regulatory body will announce its decision by Jan 9, 2015 instead of Oct 9, 2014.

Impax is looking to get Rytary approved for the treatment of patients suffering from idiopathic Parkinson's disease. The company plans to submit for EU approval later this year.

Impax had resubmitted the NDA for Rytary in Apr 2014. However, the company subsequently amended the chemical, manufacturing and control (CMC) section of the resubmitted NDA after the submission of responses to Form 483 observations related to the Taiwan manufacturing facility. The FDA had issued a Form 483 in July this year, after it had inspected the Taiwan facility.

With the amendment being treated as a major change and the submission being made within three months of Oct 9, 2014, the U.S. regulatory body extended the date to review the information. The agency did not ask the company for any other additional information.

We note that Impax has been hampered by quality control issues since 2011. In May 2011, Impax had received a warning letter from the FDA after an inspection of the company’s facility at Hayward, CA. Subsequently, the company received a Form 483.

The company suffered yet another setback when the FDA conducted a re-inspection of the concerned facility in August this year. The outcome of the re-inspection was not positive for Impax and the FDA issued a new Form 483 with 7 observations.

Impax currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the health care sector can consider Mallinckrodt (MNK), Akorn, Inc. (AKRX) and Acura Pharmaceuticals, Inc. (ACUR). While Mallinckrodt and Akorn carry a Zacks Rank #1 (Strong Buy), Acura is a Zacks Rank #2 (Buy) stock.

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