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Stock Market & Financial Investment News

News Breaks
June 17, 2014
12:35 EDTHSP, CBSTHospira granted tentative approval for generic daptomycin
Hospira (HSP) was granted tentative approval for generic daptomycin, according to a post to the FDA's website dated June 16. Daptomycin is an antibiotic used in the treatment of infections caused by Gram-positive organisms that is sold under the trade name Cubicin by Cubist Pharmaceuticals (CBST). Reference Link
News For HSP;CBST From The Last 14 Days
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June 24, 2015
07:06 EDTHSPHospira: FDA deems India facility 'acceptable' for manufacturing
Hospira said in a regulatory filing that on June 23, Hospira Healthcare India Private Limited, a subsidiary of Hospira, received official notification from the U.S. FDA that the inspection of the Visakhapatnam, India facility was deemed acceptable for the manufacture of finished dosage drugs. As a result of this action, the company may receive U.S. product approvals from this facility in the future. As was previously reported, the FDA conducted a pre-approval inspection of the Vizag facility from February 16 to February 25, which resulted in the issuance of a Form 483 containing 14 observations. Hospira responded to the Form 483 on March 18, and submitted additional support documentation on May 29. The inspection was found to be acceptable following the FDA’s review of the company’s responses and support documentation. The company has begun limited commercial production at the facility.

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