Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 16

Results For "USFDA"

1130 News Found

Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets
Drug Approval | June 14, 2024

Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets

Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of US$ 77.9 mn in the United States (IQVIA MAT March 24).


Shilpa Biologicals files Type IV DMF of recombinant Human Albumin 20% with USFDA
Drug Approval | June 06, 2024

Shilpa Biologicals files Type IV DMF of recombinant Human Albumin 20% with USFDA

This novel recombinant has been developed and is a patented novel recombinant Human Albumin 20% process


Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets
Drug Approval | May 30, 2024

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death


Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL
Drug Approval | May 29, 2024

Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL

Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation


Zydus receives final approval from USFDA for Theophylline ER Tablets
Drug Approval | May 25, 2024

Zydus receives final approval from USFDA for Theophylline ER Tablets

Theophylline is used to treat asthma and chronic obstructive pulmonary disease


Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi approved by USFDA
Diagnostic Center | May 20, 2024

Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi approved by USFDA

95.7% of patients responded to Breyanzi in the TRANSCEND FL trial


Zydus receives final approval from USFDA for Dexamethasone Tablets
Drug Approval | May 13, 2024

Zydus receives final approval from USFDA for Dexamethasone Tablets

Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)


Strides receives USFDA approval for Sevelamer Carbonate Tablets
Drug Approval | May 11, 2024

Strides receives USFDA approval for Sevelamer Carbonate Tablets

Sevelamer Carbonate Tablets approval consolidates the company's position in the Sevelamer segment


Alembic Pharmaceuticals receives 5 USFDA product approvals in Q1 FY25
Drug Approval | May 10, 2024

Alembic Pharmaceuticals receives 5 USFDA product approvals in Q1 FY25

Receives 3 final and 2 tentative product approvals thus far in Q1FY25


Cipla receives 1 observation from USFDA for Kurkumbh facility
Drug Approval | May 10, 2024

Cipla receives 1 observation from USFDA for Kurkumbh facility

The company is committed to address this observation comprehensively within stipulated time