• Products
  • Suppliers
  • Sourcing Requests
Post Sourcing Request Exhibition
Get alerted on the PharmaSources E-Newsletter and Pharma Sources Insight E-Compilation!
Note: You can unsubscribe from the alerts at any time.
Advertising
New Products
Gelatin, Soft Capsule Gelatin, Hard Capsule Gelatin, Pharmaceutical Gelatin-Foodmate
Neohesperidin
Advantame
Cleanroom Bench Horizontal Laminar Flow Hood Airflow Clean Bench
Pharma and Food Grade, USP/FCC Neotame Sweetener E961
Trilobatin

Shilpa Medicare gets US FDA tentative nod for Apremilast Tablets

expresspharmaMarch 05, 2021

Tag: Shilpa , Apremilast Tablets , ANDA , FDA

Shilpa Medicare has received US Food and Drug Administration (US FDA) tentative approval for its ANDA, Apremilast Tablets, 10 mg, 20 mg, and 30 mg dated 04 Mar 2021. The ANDA was filed as ‘First to File’ submission on NCE -1 date to seek eligibility for 180 days exclusivity.

Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene used in the treatment of ‘psoriatic arthritis’ as recommended in the label approved by FDA.

According to IQVIA MAT Q2 2020 data, the US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is approximately $2.4 billion.

Previous:COVID-19 has fast-tracked digital transformation timeline for pharma industry: GlobalData

Next:EMA initiates rolling review of Russia’s Sputnik V vaccine for Covid-19

Related News

Everest Medicines Announces Acceptance of the New Drug Application for VELSIPITY

Everest Medicines LimitedDecember 20, 2024

Everest Medicines announced NMPA acceptance of NDA for VELSIPITY(R) (etrasimod) to treat moderately to severely active UC.

Manulife Hong Kong Partners with New Frontier Group to Enhance Cross-Border Healthcare Services

PRNewswireDecember 12, 2024

Menarini Group and MEDSIR Present the Phase III Study ADELA: A New Therapeutic Strategy for Advanced Breast Cancer

PRNewswireDecember 12, 2024

Shilpa Medicare gets US FDA tentative nod for Apremilast Tablets | Pharmasources.com

Core8 Group and MedArmor to Pioneer Vietnam's First AI x ESG Hospital

PRNewswireDecember 12, 2024

Core8 Group, an Australian leader in high-tech and biotech innovation, has unveiled plans to develop Vietnam's first AI x ESG Hospital, marking a significant milestone in healthcare transformation.

You may like
More>>

Pressure vessel and non - standard series

Pressure vessel and non - standard series
Marya Pharmaceutical GMP Standard Dust Free Cleanroom Turnkey Project with HVAC System

Marya Pharmaceutical GMP Standard Dust Free Cleanroom Turnkey Project with HVAC System
PBT elastic bandage

PBT elastic bandage
Refrigerated Circulators with Standard Digital Temperature Controllers

Refrigerated Circulators with Standard Digital Temperature Controllers
Bleomycin sulfate (FDA)

Bleomycin sulfate (FDA)
EP/USP standard Prednisolone Acetate 52-21-1

EP/USP standard Prednisolone Acetate 52-21-1
LGJ-100F Standard Type Experimental Freeze Dryer

LGJ-100F Standard Type Experimental Freeze Dryer
Milk thistle standardized extract

Milk thistle standardized extract
toc standard method

toc standard method
National Standard of chlorinated paraffin

National Standard of chlorinated paraffin

Contact Us

PharmaSources@imsinoexpo.com

Tel: (+86) 400 610 1188

WhatsApp/Telegram/Wechat: +86 13621645194

About Us
About PharmaSources
Terms of Service
Privacy Policy
Intellectual Property
Media Partners
Buy
Search Products
Post Sourcing Requests
Search Suppliers
CAS Search
Sell
Member Application
Advertising
Post Products
EZSourcing
Events
CPHI China
PMEC China
Conferences
Search Events
Help
FAQ
Contact Us
Feedback
PharmaSources Customer Service