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parryashford

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active 16 hours, 16 minutes ago

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Latest updates

The Paragraph Four Report®
Paragraph IV Activity for October 2020

New Certifications as reported by FDA on October 20, 2020

1. Epinephrine Injection 1mg/mL on 8/13/2020

Comments: Epinephrine has appeared on the PIV List and in PIV cases in the past. This particular filing appears to be the first ANDA filed.

New Cases Filed

1.…[Read more]

4 weeks ago

Xiidra®(lifitegrast) Ophthalmic Solution
Annual Sales $192M
Company NOVARTIS
Date of First Filing July 13, 2020

Paragraph IV Applicant: Aurobindo
Case Name: NOVARTIS PHARMACEUTICALS CORPORATION v. AUROBINDO PHARMA LTD et al
Court/Case #: Delaware District Court (dedc) 1:2020cv01426
Date Filed: 10/23/20
Judge: Stark
Product…[Read more]

1 month ago

Qbrexza®(glycopyrronium) Topical Cloth
Annual Sales
Company DERMIRA (ELI LILLY)
Date of First Filing January 13, 2020

Paragraph IV Applicant: Perrigo
Case Name: DERMIRA INC et al v. PERRIGO PHARMA INTERNATIONAL DAC
Court/Case #: Delaware District Court (dedc) 1:2020cv01413
Date Filed: 10/21/20
Judge:
Product Strength:…[Read more]

1 month ago

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