PremiumGujarat-based drugmaker Zydus Cadila has received tentative approval from the US Food and Drug Administration (FDA) to market the Ibrutinib tablets used in the treatment of certain types of cancers.
The company will now be able to market the tablets in the strengths of 140 mg, 280 mg, 420 mg and 560 mg, it said in a statement on Wednesday.
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, it added.
"Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia," Zydus Cadila said.
The group now has 319 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of its filing process, the company added.
Zydus Covid vaccine
The company has applied for the emergency use approval of its Covid-19 vaccine in India. However, a nod from the Drugs Controller General of India (DCGI) may take a few more days as it is required to submit additional data related to the immunogenicity and safety of its Zycov-D vaccine.
The DCGI's SEC will examine the additional data that will be submitted by the pharma company this week. If the data is found to be satisfactory, then the final approval from DCGI may be granted in August, reported news agency ANI.
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