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Home→Published 2021 → January

Monthly Archives: January 2021

2020 Annual Review – Market Correction

ParagraphFour.com Posted on January 14, 2021 by parryashfordJanuary 14, 2021

Six months ago, I posted that the First Half of 2020 showed that the PIV Market was correcting itself. The FDA PIV List showed that fewer products receiving their first PIV certifications had multiple filers. This seemed to be a natural market correction — over the past few years, the PIV Market saw several products … 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 5 days, 20 hours 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 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, 3 weeks ago
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