Xadago®(safinamide) Tablets
Annual Sales
Company NEWRON
Date of First Filing March 22, 2021
Paragraph IV Applicant: Aurobindo
Case Name: NEWRON PHARMACEUTICALS SPA et al v. AUROBINDO PHARMA LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2021cv00843
Date Filed: 6/10/2021
Judge:
Product Strength: 50mg and…Read more
The Paragraph Four Report®
Paragraph IV Activity for May 2021
New Certifications as reported by FDA on May 4 and 20, 2021
1. Xadago®(safinamide) Tablets 50mg and 100mg on 3/22/2021
2. Xtandi®(enzalutamide) Tablets 40mg and 80mg on 3/31/2021
3. Kisqali Femara Co-Pack®(ribociclib and letrozole (copackaged)) Tablets 200mg and 2.5mg on 3/1…Read more
Minocin®(minocycline) Injection
Annual Sales
Company MELINTA
Date of First Filing October 16, 2020
Paragraph IV Applicant: Nexus
Case Name: MELINTA THERAPEUTICS LLC et al v. NEXUS PHARMACEUTICALS
Court/Case #: New Jersey District Court (njdc) 2:2021cv11198
Date Filed: 5/13/21
Judge: Martinotti
Product Strength: 100…Read more
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