Lupin gets USFDA approval for Doxycycline Hyclate Delayed-Release Tablets USP

Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).

Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma

ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity

Eugia Pharma receives USFDA Approval for Icatibant Injection

This is the 166th ANDA out of Eugia Pharma Speciality Group facilities

Lupin receives USFDA approval for fluocinolone acetonide body oil

Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)

Granules India received USFDA approval for the ANDA filed for metoprolol succinate ER tablets

Eugia Pharma receives USFDA approval for Vancomycin Hydrochloride for Injection USP

The product is being launched in August 2023

Eugia Pharma receives USFDA approval for Plerixafor Injection

The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023

Alembic Pharmaceuticals receives USFDA approvals for 5 products in Q1FY24

Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.

Lupin receives USFDA approval for Tiotropium Dry Powder Inhaler

This product will be manufactured at Lupin's Pithampur facility in India

Lupin receives USFDA approval from Obeticholic Acid Tablets

Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).