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Apotex Inc.

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Latest From Apotex Inc.

ANDA Submissions Drop To Start FY 2021, Perhaps Forced Down By COVID-19

First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.

Generic Drugs Drug Review

Apotex Loses Again On Alternate Salt Alimta In US

Apotex’ 505(b)(2) new drug application rival to Alimta will stay off the US market after the Federal Circuit found that a lower court had correctly concluded that prosecution history estoppel did not bar Lilly’s infringement claims against the Canadian firm under the doctrine of equivalents.

Intellectual Property Legal Issues

Perrigo Among Firms Requesting Delay In Conducting US Nitrosamine Risk Assessments

Perrigo, Pfizer want FDA to postpone its March deadline for conducting nitrosamine risk assessments. Generics executive cites “serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.

OTC Drugs Guidance Documents

Executive Decisions: Hardwick Heads US Apotex, Stada Adds To German Management, Lovett Leads Nutrition21 Marketing, More

Hardwick heads Apotex in US; DSM expands cycling team support; Stada adds to Germany management; Lovett leads Nutrition21 marketing; Viatris appoints head of capital markets; and Redcon1 sponsors bodybuilder Greene, wrestler Omega.

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