New Delhi: Cadila Healthcare on Wednesday said its group firm Zydus Cadila has received final approval from the US health regulator to market blood pressure drug, Tiadylt ER.
The approval by the US Food and Drug Administration (USFDA) for diltiazem hydrochloride (Tiadylt ER) extended release capsules is for multiple strengths of 120mg, 180mg, 240mg, 300mg and 420mg, Cadila Healthcare said in a BSE filing.
“The drug will be manufactured at the group’s formulations manufacturing facility at pharma SEZ in Ahmedabad,” it added.
Besides blood pressure, diltiazem hydrochloride is also prescribed for angina and certain heart rhythm disorders, it added.
Cadila Healthcare further said the group has also received final approval from the USFDA to market azelastine hydrochloride 137 mcg nasal pray, which is used in treatment of runny nose, sneezing and post nasal drip caused by allergies.
The spray will be produced at the group’s formulations manufacturing unit at Moraiya, Ahmedabad.
With the latest approvals from the USFDA, the group now has more than 140 approvals and has so far filed over 300 abbreviated new drug applications.