Cadila Healthcare informed that it has received final approval from the United States Food and Drug Administration (USFDA) to market Erlotinib tablets in the strengths of 25 mg, 100 mg, and 150 mg.
Erlotinib, a bioequivalent to the reference listed drug product (RLD) Tarceva tablets, is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body. It is also used to treat non-small cell lung cancer or pancreatic cancer that has spread to other parts of the body (metastatic). Erlotinib is usually given after other cancer medicines have been tried without success.
Cadila said that the drug will be manufactured at the group's formulation manufacturing facility at the SEZ, in Ahmedabad.
The group now has 288 approvals and has so far filed over 386 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04. The announcement was made during market hours today.
Shares of the drug maker was down 2.62% at Rs 334.55. The stock has hit a low of Rs 333.25 and a high of Rs 350.40 so far during the day.
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On a consolidated basis, the drug maker's net profit tanked 26.54% to Rs 375.18 crore on a 0.52% rise in net sales to Rs 3,534.50 crore in Q3 December 2019 Q3 December 2018.
The company is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.
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