USFDA’s ODAC recommends approval of Mylan and Biocon’s proposed Biosimilar Trastuzumab
Mylan N.V. and Biocon on Friday announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies’ proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin, which include HER2-positive breast cancer in the metastatic and adjuvant settings. Read More
Zydus gets final approval from USFDA for Memantine Hydrochloride tablets
Zydus Cadila, in a BSE filing on Wednesday, said that the company has received the final approval from the USFDA to market Memantine Hydrochloride tablets USP, 5 mg and 10 mg.
The drug is used for the treatment of moderate to severe dementia (Alzheimer’s type) and will be produced at the group’s facility in Moraiya, Ahmedabad. Read More
Piramal to expand overseas pharma biz
Mumbai-headquartered, Piramal Enterprises has plans to introduce more products going forward and it is looking to expand the presence of its pharma vertical in strong global markets such as the US, Europe and Japan.
Europe and North America contribute over 70% of the company's revenue from pharmaceuticals business. Read More
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