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Amphastar Stock Down on CRL for Asthma Drug in the U.S.

Amphastar Pharmaceuticals, Inc.AMPH announced that its subsidiary, Armstrong Pharmaceuticals, Inc., has received a Complete Response Letter (CRL) from the FDA for a New Drug Application for its over-the-counter (OTC) bronchodilator product, Primatene Mist (epinephrine inhalation aerosol). The company's shares lost 9.1% following the news.

Amphastar's one-month share price movement shows that the stock has underperformed the Zacks classified Medical - Generic Drugs industry. Specifically, the company gained 0.5%, while the industry improved 1.5%.

The CRL has requisitioned changes in the candidate's label as well as packaging. The FDA also necessitated another Human Factor validation study to measure consumers' ability to use the product without consultation with a doctor or a pharmacist.

In 2013, the company filed an NDA for Primatene Mist and received a Prescription Drug User Fee Act date in May 2014. However, in May 2014, the company received a CRL from the FDA, asking for additional non-clinical information, label revisions and follow-up studies to assess consumers' ability to use the device correctly to support its approval in the OTC setting. The company met with the FDA in Oct 2014 to discuss preliminary data results and to clarify the requirements for further studies. The company received advice regarding its ongoing studies from the FDA in Jan 2016, and completed the human factor studies accordingly. Thereafter, Amphastar submitted the amended NDA on Jun 28, 2016 and received a target response date of Dec 28, 2016.

The company now plans to work with the FDA during the post-action phase to address the regulatory agency's concerns by mid 2017.

Note that Primatene Mist offers a new inhalation delivery system, which no longer consists of chlorofluorocarbons (CFCs). This comes as part of an international environmental treaty aimed at phasing out CFCs from various products.

AMPHASTAR PHARM Price

AMPHASTAR PHARM Price | AMPHASTAR PHARM Quote

Zacks Rank & Key Picks

Amphastar currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Heska Corporation HSKA , Cambrex Corporation CBM and Vanda Pharmaceuticals Inc. VNDA . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

Heska's earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 86.7% year to date.

Cambrex's earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 15% year to date.

Vanda's loss estimates have narrowed from 62 cents to 45 cents for 2016 over the last 60 days. The company has posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price surged 72.9% year to date.

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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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