PITTSBURGH _ Mylan's shares surged 16.2 percent in trading Wednesday on news that the drugmaker had received long-anticipated approval from the U.S. Food and Drug Administration to market a generic version of Teva's top-selling multiple sclerosis drug Copaxone. Shares closed trading at $37.80.
The approvals _ for 20 milligram and 40 milligram doses _ "reinforce our proven capabilities in bringing complex and difficult-to-manufacture products to market," CEO Heather Bresch said in a statement.
The nod followed Monday's announcement by the FDA that it would introduce new measures aimed at bringing generic versions of complex drugs to market faster in an effort to battle the high cost of pharmaceuticals.
Mylan had faced years of setbacks involving generic Copaxone. The company had expected to win approval as far back as 2014.
Mylan, which reincorporated in The Netherlands but is run from executive offices in suburban Pittsburgh, said it expected to begin shipping the product "imminently."
Copaxone is prescribed for relapsing forms of MS, a disease of the central nervous system. Annual sales for the brand's 20 mg and 40 mg dosages were about $4.3 billion, Mylan said.
