Generic Launches - Abbreviated New Drug Applications and 505(b)(2) Applications

Robins Kaplan LLP
Contact
LinkedIn
Facebook
X
Send
Embed

Robins Kaplan LLP

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.

Reference Listed Drug ANDA Holder Generic Drug Name ANDA
Applicant(s)		 Indication Launch Date
Abraxane Bristol-Myers Squibb paclitaxel Teva Used to treat various types of cancer. Indications for using paclitaxel encompass a range of cancers, including breast, ovarian, bladder, lung, prostate, melanoma, esophageal, Kaposi sarcoma, and various other solid tumors. 7/2/2024
Lunesta Waylis eszopiclone Camber Used to treat insomnia. 6/7/2024
Focinvez Steriscience fosaprepitant dimeglumine Steriscience / Amneal Used to prevent: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). 7/9/2024
Tirosint IBSA levothyroxine sodium Yaral Used to treat primary, secondary, and tertiary hypothyroidism. 7/9/2024
Thiola EC Travere tiopronin Endo Used to prevent kidney stones in patients with severe homozygous cystinuria (too much cystine in the urine).  7/15/2024
Zinc Sulfate American Regent zinc sulfate Apotex Used as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated 8/1/2024
Doxil Baxter Healthcare doxorubicin Lupin Used to treat Ovarian Cancer, Acquired Immune Deficiency Syndrome (AIDS)-related Kaposi’s Sarcoma, and Multiple Myeloma. 8/29/2024
Myrbetriq ER Astellas mirabegron Lupin Used to manage overactive bladder. 9/4/2024
Sprycel Bristol-Myers Squibb dasatinib Apotex Used to treat certain types of leukemia in both adults and children 1 year of age and older, including cases where previous treatment were not effective or tolerated. 9/5/2024
Oxtellar XR Supernus oxcarbazepine Apotex Used to treat partial-onset seizures in patients 6 years of age and older. 9/5/2024
Foscavir Clinagen foscarnet sodium Hikma Used to treat CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). 9/23/2024
Narcan Adapt naloxone Teva Used to rapidly reverse opioid overdose. 9/23/2024

[View source.]

Send Print Report

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

© Robins Kaplan LLP

Written by:

Robins Kaplan LLP
Robins Kaplan LLP
Contact
more
less

PUBLISH YOUR CONTENT ON JD SUPRA NOW

  • Increased visibility
  • Actionable analytics
  • Ongoing guidance

Robins Kaplan LLP on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign Up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide