Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data
The company had responded to the agency and carried out the required corrective actions.
The approval further strengthens the Potassium Chloride franchise for the company.
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data
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