Zydus receives final approvals from USFDA for Baclofen and Erlotinib tablets

Zydus Cadila has received final approval from the USFDA to market Baclofen tablets, 5 mg. Baclofen is used to treat muscle spasms caused by certain conditions such as multiple sclerosis and spinal cord injury/disease. It works by helping to relax the muscles. It will be manufactured at the group’s formulations manufacturing facility at Baddi.

The company has also received final approval from the USFDA to market Erlotinib tablets (US RLD: Tarceva tablets), in the strengths of 25 mg, 100 mg, and 150 mg. Erlotinib 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. 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 ANDAs since the commencement of the filing process in FY 2003-04.

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