NEW DELHI: Drug firm Zydus Cadila on Saturday said it has received final approval from the US health regulator to market generic Butalbital, Acetaminophen and Caffeine combination tablets to treat symptoms of tension headaches.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Butalbital, Acetaminophen and Caffeine tablets in strengths of 50mg/325mg/40 mg, Zydus Cadila said in a statement.
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The drug will be manufactured at Nesher Pharma’s manufacturing facility at St. Louis in the US, it added. This combination medication is used to treat symptom complex of tension (or muscle contraction) headaches, Zydus Cadila said.
The group now has 294 approvals and has filed over 390 abbreviated new drug applications (ANDAs) since the commencement of the filing process, it added.