Generic drug maker gets FDA preliminary thumbs up
US-based Handa Pharmaceuticals LLC has perceived a initial green light from a US Food as well as Drug Administration (FDA) to sell a general version of a popular antipsychotic-medication Seroquel XR (quetiapine).
Fremont, California-based Handa pronounced final week which a application to sell a general version of AstraZeneca's Seroquel XR has been postulated tentative capitulation by a US FDA.
Biopharmaceutical association AstraZeneca is headquartered in London.
The drug is also used to treat bipolar commotion (manic depression) as well as vital depressive commotion in adults.
Nearly 70 percent of all Chinesepharmaceutical companies have been general drug producers, but this is a initial time a producer with Chinese ties has won a capitulation process.
According to a Hatch-Waxman Act expelled in a US in 1984, a initial successful challenger of a law drug is postulated selling exclusivity for 180 days, which has turn a vital goal for general drug producers with clever R&D capabilities, pronounced Bill Liu, CEO of Handa.
As a initial challenger, Handa is entitled to 180 days of selling exclusivity, during which pick general drugs have been not authorised to get in to a market.
Vice president of Fosun Pharmaceutical, Cui Zhiping, pronounced in a press recover which general drugs, especially those constructed prior to a obvious expired, have huge marketplace potential by providing a cheaper pick to patients.
Fosun Pharmaceutical invested in Handa in 2009, as well as currently owns about 10 percent of a company. "Handa has a clever R&D team, which could help improve Fosun's investigate ability," pronounced Cui.
Source: Global Times
Fremont, California-based Handa pronounced final week which a application to sell a general version of AstraZeneca's Seroquel XR has been postulated tentative capitulation by a US FDA.
Biopharmaceutical association AstraZeneca is headquartered in London.
The drug is also used to treat bipolar commotion (manic depression) as well as vital depressive commotion in adults.
Nearly 70 percent of all Chinesepharmaceutical companies have been general drug producers, but this is a initial time a producer with Chinese ties has won a capitulation process.
According to a Hatch-Waxman Act expelled in a US in 1984, a initial successful challenger of a law drug is postulated selling exclusivity for 180 days, which has turn a vital goal for general drug producers with clever R&D capabilities, pronounced Bill Liu, CEO of Handa.
As a initial challenger, Handa is entitled to 180 days of selling exclusivity, during which pick general drugs have been not authorised to get in to a market.
Vice president of Fosun Pharmaceutical, Cui Zhiping, pronounced in a press recover which general drugs, especially those constructed prior to a obvious expired, have huge marketplace potential by providing a cheaper pick to patients.
Fosun Pharmaceutical invested in Handa in 2009, as well as currently owns about 10 percent of a company. "Handa has a clever R&D team, which could help improve Fosun's investigate ability," pronounced Cui.
Source: Global Times
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