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
Parsabiv®(etelcalcetide) Injection
Annual Sales $630M
Company AMGEN
Date of First Filing February 8, 2021
Paragraph IV Applicant: Aurobindo
Case Name: AMGEN INC et al v. AUROBINDO PHARMA LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2021cv00662
Date Filed: 5/6/21
Judge:
Product Strength: 2.5mg/0.5mL, 5mg/mL, and…Read more
The Paragraph Four Report®
Paragraph IV Activity for April 2021
New Certifications as reported by FDA on April 6 and 20, 2021
1. Parsabiv®(etelcalcetide) Injection 2.5mg/0.5mL, 5mg/mL, and 10mg/2mL on 2/8/2021
2. Tiglutik®(riluzole) Oral Suspension 50mg/10mL on 3/12/2021
3. Lexette®(halobetasol) Topical Foam 0.05% on 1/2…Read more
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