AstraZeneca announces Bevespi Aerosphere’s U.S. availability
WILMINGTON, Del. — AstraZeneca on Monday announced the availability of its Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol in the United States. The drug is indicated for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis or emphysema.
Bevespi Aerosphere was approved by the Food and Drug Administration in April 2016, and the company said it’s the first product approved using its co-suspension technology, which it says allows for consistent delivery of one or more medicines from the same pressurized metered dose inhaler.
“At AstraZeneca, we are committed to following the science to improve the lives of people living with respiratory diseases,” AstraZeneca VP U.S. respiratory Tosh Butt said. “I’m thrilled that Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol is now available in pharmacies across the US.”
FDA approves Egalet’s abuse-deterrent morphine Arymo ER
SILVER SPRING, Md. — The Food and Drug Administration has approved Arymo ER (morphine sulfate), an extended-release morphine tablet with abuse-deterrent properties, the company announced Monday.
The drug is indicated to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative options are inadequate. Egalet said Arymo ER is the first drug approved using its proprietary Guardian Technology, which works to deter abuse and prevent the tablets from being manipulated for abuse or misuse.
With the majority of ER opioids in easy to abuse forms, it is important that healthcare professionals have additional treatment options like Arymo ER that are resistant to different methods of manipulation using a variety of tools,” Egalet president and CEO Bob Radie, said. “Arymo ER has physical and chemical properties expected to make abuse by injection difficult, which is important given it is the most common non-oral route of morphine abuse and the most dangerous.”
Arymo ER was approved in 15-, 30- and 60-mg dosage strengths and the company expects a launch in the first quarter of 2017.
Teva completes sale of U.K., Ireland Actavis business to Intas’s Accord Healthcare
BY DSN STAFF
JERUSALEM and AHMEDABAD, India — The sale of Teva’s Actavis U.K. and Actavis Ireland to Intas Pharmaceuticals through its subsidiary Accord Healthcare for £603 million, Intas announced Tuesday. The transaction is part of the European Commission’s antitrust divestiture requirements surrounding Teva’s acquisition of Allergan’s generics business.
“The completion of this acquisition captures a great opportunity for growth and demonstrates Intas' commitment to greater European expansion,” Intas vice chairman and managing director Binish Chudgar said. “The joining of these two companies means we can continue our successful European operating path, which started more than a decade ago. … Through our subsidiary, Accord Healthcare, we are welcoming the Actavis team into the Intas family and will ensure a smooth integration of the two businesses.”
The deal strengthens Accord’s U.K. and Ireland footprints, expanding its manufacturing presence with the addition of Actavis’s GMP Barnstaple site and bringing its workforce in the region to more than 1,000 employees.
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