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Home→Published 2020 → February

Monthly Archives: February 2020

FTC Resumes Attacks on PIV Settlements

ParagraphFour.com Posted on February 26, 2020 by parryashfordFebruary 27, 2020

The Federal Trade Commission has resumed its attacks on PIV Settlements, claiming greater access to generic products for consumers. Considering the history and PIV data, these new and unfounded attacks likely serve to reduce the number of generics reaching the market. Supreme Court Rule of Reason The US Supreme Court issued FTC v. Actavis in … Continue reading →

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The Paragraph Four Report®
Paragraph IV Activity for February 2021

New Certifications as reported by FDA on February 8 and 23, 2021

1. Katerzia®(amlodipine) Oral Suspension 1 mg/mL on 12/29/2020
2. Balcoltra®(levonorgestrel and ethinyl estradiol) 0.1 mg/0.02 mg 7/14/2020
3. Osphena®(ospemifene) Tablets 60 mg on 12/29/2020
4. Car…Read more

Profile picture of parryashford 1 week, 2 days ago

The Paragraph Four Report®
Paragraph IV Activity for January 2021

New Certifications as reported by FDA on January 26, 2021

1. Tirosint®(levothyroxine) Capsules 112 mcg on 12/18/2020
2. Ibrance®(palbociclib) Tablets 75 mg, 100mg, and 125mg on 11/24/2020
3. Xeljanz XR®(tofacitinib) Extended-release Tablets 22 mg on 12/28/2020
4. Ore…Read more

Profile picture of parryashford 1 month, 1 week ago

Makena®(hydroxyprogesterone) Injection
Annual Sales
Company COVIS PHARMA (AMAG)
Date of First Filing September 28, 2020

Paragraph IV Applicant: Aurobindo
Case Name: COVIS PHARMA GMBH et al v. EUGIA PHARMA SPECIALTIES LTD et al
Court/Case #: Delaware District Court (dedc) 1:2021cv00003
Date Filed: 1/4/21
Judge: Connelly
Product…Read more

Profile picture of parryashford 1 month, 4 weeks ago
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