Drug Approval | 16 June 2023
Bliss GVS Pharma updates on inspection by USFDA
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
The company will submit its comprehensive response on these observations to the US FDA
Granules now has a total of 58 ANDA approvals from US FDA
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)
Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)
Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time
Injectafer is now the first and only intravenous (IV) iron replacement therapy indicated for adult patients with heart failure who have iron deficiency
European approval is based on robust Phase III data showing Cosentyx provided rapid symptom relief from as early as Week 4, with response rates continuing to improve up to 1 year1,3-5
Tremelimumab in combination with Durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC)
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).
For the treatment of Superficial Femoral Artery
The product is expected to be launched in June 2023
The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans
This is the second US FDA GMP inspection of this facility within one year
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