Ambio obtains FDA OK for generic Forteo for partner Apotex
Ambio announced that a generic version of Forteo (teriparatide injection) developed by Ambio and to be marketed and sold by Apotex has been approved by the Food and Drug Administration.
Forteo (teriparatide injection) is indicated for the treatment of osteoporosis.
“Ambio is a world leader in developing complex peptides. Our highly skilled techniques in controlling various kinds of peptide-related synthetic impurities together with expertise in developing advanced analytical methods to thoroughly characterize the peptides sets us apart in the pharmaceutical industry,” said Simrat Singh, president of Ambio. “We are thrilled that the teriparatide injection developed by Ambio has received FDA approval.”
“The approval further validates our expertise and technological innovation as a developer and manufacturer of complex generic drugs and supports our commitment to bring high quality and affordable therapies to patients,” said Chris Bai, founder, chairman of the board and CEO of Ambio. “We are pleased to partner with Apotex in this effort which allowed them to expeditiously secure FDA approval and immediately execute product launch.”
[Read more: Teva obtains FDA nod for generic Forteo]
"The launch of Teriparatide Injection reflects Apotex's continued focus on improving access for patients to affordable complex generic drugs,” said Kiran Krishnan, senior vice president of global regulatory affairs at Apotex. "We are pleased to deliver this critical product, in partnership with Ambio, that we believe will be essential in improving the quality of life for osteoporosis patients in the United States."