Drug Approval | 23 March 2024
Zydus receives tentative approval from USFDA for Letermovir Tablets
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024
A five-day inspection was concluded successfully with no critical and no major observations raised
Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India
The company is confident of addressing the concern raised by the USFDA
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders
PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally
CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications
These approvals mark significant progress for Venus Remedies in expanding its market presence
The inspection was concluded with few procedural observations
The company will provide comprehensive response to USFDA for the observations
The validations confirm the completion of the applications and commence the scientific review process
The WHO GMP approved vertically integrated ONCOLOGY unit of SAKAR has been selling products nationally since few quarters
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty
This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently
The product will be launched in March 2024
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
The said Unit complies with the prescribed Good Manufacturing practices as per relevant WHO technical Report Series
The observations do not pose any risk to site's compliance standards or its business continuity
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