Replies to post #14141 on ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Thanks dasgrunt.

[Just the facts maam]

Dasgrunt, it looks like the first Novitium 505(b)(2) approval was for Hydroxychloroquine Sulfate tablets. While it is a tentative approval for L-GLUTAMINE which is an ANDA of Emmaus Medical Inc.'s Endari which has data Exclusivity until 07/07/2024.

The following is from the approval letter:

Dear Mr. Shanmugam:

Please refer to your new drug application (NDA) dated April 6, 2020, received April 15, 2020, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug,
and Cosmetic Act (FDCA) for hydroxychloroquine sulfate tablets.

We acknowledge receipt of your amendment dated July 22, 2021, which constituted a
complete response to our February 12, 2021, action letter.

This NDA provides for the use of hydroxychloroquine sulfate tablet for the following
indications:
- Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium
malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric
patients.
- Prophylaxis of malaria in geographic areas where chloroquine resistance is not
reported in adult and pediatric patients.
- Treatment of rheumatoid arthritis in adults.
- Treatment of systemic lupus erythematosus in adults.
- Treatment of chronic discoid lupus erythematosus in adults.

Approval letter