anda


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anda

The hemispherical dome of a stupa.
References in periodicals archive ?
Biopharmaceutical company CASI Pharmaceuticals Inc (Nasdaq:CASI) revealed on Friday the completion of the acquisition of a portfolio of 25 US FDA-approved abbreviated new drug applications (ANDAs), one ANDA that US FDA tentatively approved and three ANDAs that are pending US FDA approval.
Among the study's key conclusions is that ANDA patent litigation has risen sharply since Lex Machina's initial ANDA report in 2014.
In November 2014, the District of Delaware confronted the impact of Daimler on ANDA litigation in AstraZeneca AB v.
Lex Machina has released its third annual Hatch-Waxman/ ANDA Litigation Report.
In Hatch-Waxman litigation, the filing of an ANDA seeking approval to market a pharmaceutical product before the expiration of patents covering that product is a technical act of infringement sufficient to establish jurisdiction to resolve the issues of patent infringement and validity in litigation.
This brings the company's total number of ANDA submissions in 2014 to six, with 17 submissions now pending at the US FDA.
Approval of our first-ever ANDA provides a validation of our strategy and capabilities," claims Spectrum chairman, chief executive officer and president Rajesh Shrotriya.
This second ANDA brings the company's total number of ANDA submissions to 15, with thirteen now pending at the FDA.
The fourth quarter of 2013 will mark the three year anniversary of its first two submissions to the FDA, and, based on the FDA's current average review time of 32 months, it is hopeful to receive its first ANDA approval in 2013.