FDA approval for Impax for its antibiotic drug
The Food and Drug Administration has approved Impax Laboratories Inc.’s generic version of the antibiotic drug Adoxa.
The 150-milligram drug that was being used to treat urinary tract infections, bacterial infections and pneumonia will be launched for which Hayward-based Impax is making preparations. No more details on this were given by the company.
Market is already having generic versions of Adoxa, also known as doxycline monohydrate. Nycomed is the brand-name that the drug is marketed by.
According to Impax, last year U. S. sales of 150-milligram Adoxa were about $25 million. The data was released by a health care information company and has been concluded wholly depending on it.
For its Abbreviated New Drug Application or ANDA for its generic version of Adoxa 150 mg capsules Impax, the FDA granted approval as stated by Laboratories Inc.
Through Impax’s generic division called Global Pharmaceuticals, the company is planning product launch.
This definitely brought a surge in the shares of the company. The approval came recently about which the official announcement by the company was made on Friday. Company said that the product will be in the market soon.
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