Akorn gets FDA warning letter for another manufacturing plant

By Aakash B (Reuters) - Akorn Inc said on Tuesday it received a warning letter from the U.S. Food and Drug Administration regarding its manufacturing facility in New Jersey, the latest in a string of setbacks for the generic drugmaker. Shares of the company were down 1% at $4.67 in afternoon trading

Reuters June 26, 2019 00:07:40 IST
Akorn gets FDA warning letter for another manufacturing plant

Akorn gets FDA warning letter for another manufacturing plant

By Aakash B

(Reuters) - Akorn Inc said on Tuesday it received a warning letter from the U.S. Food and Drug Administration regarding its manufacturing facility in New Jersey, the latest in a string of setbacks for the generic drugmaker.

Shares of the company were down 1% at $4.67 in afternoon trading. They had fallen nearly 13% in trading before the opening bell on the news.

The FDA warning is the second that Akorn has received this year and follows an inspection of the company's Somerset, New Jersey-based plant in July and August 2018.

In January, the agency issued a warning letter for Akorn's other manufacturing plant in Decatur, Illinois after the drugmaker did not resolve previously highlighted violations such as failure to follow procedures to prevent contamination of drugs produced at the plant.

RBC Capital Markets analyst Randall Stanicky said the New Jersey plant is linked to less than 10% of products manufactured by Akorn, and the company's primary focus would remain on moving past the warning letter it received for its Illinois facility.

The warning letter would likely require Akorn to carry out inspections, but should not impact production at the facility, Stanicky said in a note.

The FDA had also raised concerns about an Akorn manufacturing facility in Amityville, New York, earlier this year.

In addition to troubles at certain manufacturing plants, the company has seen the departure of its Chief Executive Officer Raj Rai, following its inability to salvage a $4 billion takeover deal with Germany's Fresenius SE & Co KGaA.

The company shares have fallen 70.5% over the past 12 months.

Akorn on Tuesday said it will work to resolve all issues raised in the agency's letter and that it expects to continue production at the Somerset facility.

(Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Shailesh Kuber)

This story has not been edited by Firstpost staff and is generated by auto-feed.

Updated Date:

TAGS:

also read

France, Germany to agree to NATO role against Islamic State - sources
| Reuters
World

France, Germany to agree to NATO role against Islamic State - sources | Reuters

By Robin Emmott and John Irish | BRUSSELS/PARIS BRUSSELS/PARIS France and Germany will agree to a U.S. plan for NATO to take a bigger role in the fight against Islamic militants at a meeting with President Donald Trump on Thursday, but insist the move is purely symbolic, four senior European diplomats said.The decision to allow the North Atlantic Treaty Organization to join the coalition against Islamic State in Syria and Iraq follows weeks of pressure on the two allies, who are wary of NATO confronting Russia in Syria and of alienating Arab countries who see NATO as pushing a pro-Western agenda."NATO as an institution will join the coalition," said one senior diplomat involved in the discussions. "The question is whether this just a symbolic gesture to the United States

China's Xi says navy should become world class
| Reuters
World

China's Xi says navy should become world class | Reuters

BEIJING Chinese President Xi Jinping on Wednesday called for greater efforts to make the country's navy a world class one, strong in operations on, below and above the surface, as it steps up its ability to project power far from its shores.China's navy has taken an increasingly prominent role in recent months, with a rising star admiral taking command, its first aircraft carrier sailing around self-ruled Taiwan and a new aircraft carrier launched last month.With President Donald Trump promising a US shipbuilding spree and unnerving Beijing with his unpredictable approach on hot button issues including Taiwan and the South and East China Seas, China is pushing to narrow the gap with the U.S. Navy.Inspecting navy headquarters, Xi said the navy should "aim for the top ranks in the world", the Defence Ministry said in a statement about his visit."Building a strong and modern navy is an important mark of a top ranking global military," the ministry paraphrased Xi as saying.