Pfizer Inc. on Monday said U.S. regulators have approved its acquisition of smaller rival Hospira Inc., pending the divestiture of some sterile injectable drugs, putting the deal on track to close in early September.

Pfizer said it agreed to divest itself of four U.S. sterile injectable assets: Acetylcysteine, Clindamycin, Voriconazole and Melphalan.

Earlier in August, Pfizer agreed to make divestitures designed to guard against price rises and protect the research and development of drugs to gain European approval for the deal.

The deal, announced in February, will transform New York-based Pfizer into a leading player in the emerging market for lower-priced versions of costly biotech drugs.

Regulators have worried that the two companies, both based in the U.S., would together have a high market share for certain sterile injectable drugs, which are administered with a hollow hypodermic needle.

European regulators were also concerned that the companies might delay or discontinue production of a copycat version of Infliximab, a popular drug used to treat autoimmune diseases such as rheumatoid arthritis and Crohn's disease.

To assuage those concerns, Pfizer agreed to fully divest itself of the development, manufacturing and marketing rights of its Infliximab biosimilar drug currently in development, though it will retain marketing rights outside Europe. It also agreed to dispose of certain sterile injectable drugs that raised competition concerns in individual EU countries.

Write to Chelsey Dulaney at Chelsey.Dulaney@wsj.com

 

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(END) Dow Jones Newswires

August 24, 2015 08:45 ET (12:45 GMT)

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