Alembic Pharmaceuticals Receives USFDA Approval to Sell Generic Drug
Alembic Pharmaceuticals announced that the US health agency, US Food & Drug Administration (USFDA) has given permission to sell a generic drug that prevents heart attacks and strokes.
According to Alembic Pharma, the USFDA has granted the firm final approval for its abbreviated new drug application (ANDA) for 90 mg Ticagrelor Tablets and provisional approval for 60 mg Ticagrelor Tablets.
It further stated that the approved ANDA from the company is therapeutically equivalent to the 60 mg and 90 mg Brilinta Tablets from AstraZeneca Pharmaceuticals.
In patients with acute coronary syndrome, ticagrelor pills are recommended to lower the risk of myocardial infarction (MI), stroke, and cardiovascular (CV) death.
Alembic was among the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for 90 mg Ticagrelor Tablets, according to the pharmaceutical company.
The market for 90 mg ticagrelor tablets is expected to be worth $ 1,062 million for the 12 months ending March 2025, according to IQVIA.
The market for 60 mg ticagrelor tablets is expected to be worth USD 242 million over the course of the 12 months ending March 2025.
With 192 final and 26 tentative clearances, the pharmaceutical business based in Vadodara has now obtained a total of 218 ANDA approvals from the USFDA.
Additionally, Alembic Pharma's Diltiazem Hydrochloride Extended-Release capsules, which are used to treat hypertension, were given final USFDA approval.
Diltiazem Hydrochloride Extended-Release capsules can be taken either by itself or in combination with other antihypertensive drugs to treat hypertension.
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They are also used to treat angina brought on by coronary artery spasms and chronic stable angina.