Bayer AG shares surged over 5 percent on the German stock exchange after the U.S. Food and Drug Administration approved its label update for its Essure birth control contraception and a report by The Wall Street Journal that the U.S. has approved its antitrust deal to acquire Monsanto.
The FDA put a restriction on sales for Bayer’s Essure to ensure women taking the contraception had all information pertaining the product, especially the risks. The move will restrict sales to facilities and doctors that offer birth control related products.
The FDA required that Bayer provided an updated label for the products, which Bayer shortly after released a statement saying that the FDA has approved the new label.
The new label on Essure states that sale and distribution of Essure is restricted to healthcare providers who counsel patients according to the approved label, but the benefit/risk profile of Essure has not changed and remains positive.
“Patients deserve the most accurate and comprehensive information to help them make their healthcare decisions, and Bayer has educated and continues to educate healthcare providers about the importance of appropriately counseling each patient on the benefits and risks of Essure. The FDA requested we update the label to emphasize this point.” said Bayer.
On Tuesday as well, The U.S. Justice Department decided to approve Bayer’s deal to acquire Monsanto for an acquisition valued at more than $60 billion, after the companies pledge to sell off additional assets to secure government antitrust approval, according to the Wall Street Journal, citing sources familiar with the matter.
The deal was on hold because the Justice Department was unsure about the matter of the deal.
Bayer Chief Executive Werner Baumann and Monsanto Chief Executive Officer Hugh Grant recently met with Justice Department officials in Washington to secure the agreement, said sources.
Under the agreements, Bayer will sell seed and treatment assets and agree to yield partial ownership of its digital agriculture business.. BASF will acquire the divested assets.
Bayer declined to comment on the report, but said previously in a statement that it expects the closing of the Monsanto acquisition in the second quarter.