New Delhi: Zydus Cadila has received final approval from the US health regulator to market Doxycycline Hyclate delayed-release tablets, used to treat bacterial infections. Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market the drug in the strengths of 75 mg, 100 mg and 150 mg, the company said in a BSE filing.
Zydus Cadila said the drug will be produced at the group’s formulations manufacturing facility at SEZ, Ahmedabad.
The group has also received tentative approval for Febuxostat tablets in the strengths of 40 mg and 80 mg, used to treat hyperuricemia (constantly high levels of uric acid) in adults who have gout.
The group has more than 241 approvals, and so far filed over 340 abbreviated new drug applications (ANDAs) since it started filings in 2003-04.
Shares of Cadila Healthcare, the listed entity of the group, were trading 0.13 per cent lower at Rs 341.60 per scrip on BSE.