This launch builds upon Hikma’s leading position as one of the largest US providers of nasally administered medicines used for treating seasonal allergies and advances its objective of growing its specialty business in the US
With the receipt of the EIR, the inspection stands successfully closed.
Lutio has the potential to offer significant cost savings when available to UK patients.
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
The company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner
The drug is expected to cater to the fast growing Rheumatoid Arthritis, Plaque Psoriasis, JIA, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohns disease, HS and Uveitis markets
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs.
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
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