Drug Approval | 05 July 2023
Zydus receives final approval from the USFDA for Oxcarbazepine Tablets
The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)
The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12
Supply readiness follows months of manufacturing to ensure timely and ample supply
The company will submit its comprehensive response on these observations to the USFDA
This product will be manufactured at Lupin's Pithampur facility in India
This trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable
The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
The inspection closed with the facility receiving an inspection classification of NAI
Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products
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
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