Latest news with #BrilintaTablets
The Hindu
02-05-2025
- Health
- The Hindu
Alembic Pharma's generic Ticagrelor tablets gets U.S. FDA nod
Alembic Pharmaceuticals has received U.S. Food and Drug Administration final approval for an abbreviated new drug application for Ticagrelor Tablets 90 mg and tentative approval for Ticagrelor Tablets 60 mg. The approved ANDA is therapeutically equivalent to the reference listed drug Brilinta Tablets, 60 mg and 90 mg, of AstraZeneca. Ticagrelor tablets are indicated to reduce the risk of cardiovascular death, myocardial infarction (MI) and stroke in patients with acute coronary syndrome or a history of MI. For Ticagrelor Tablets 90 mg, Alembic was one of the first to submit a substantially complete ANDA with a paragraph IV certification. The estimated market size of Ticagrelor Tablets 90 mg was $1,062 million for twelve months ending March 2025. Ticagrelor Tablets 60 mg had an estimated market size of $242 million during the same period, the company said citing IQVIA numbers. The tablet is also indicated to reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS; to reduce risk of a first MI or stroke in patients with coronary artery disease; and to reduce the risk of stroke in patients with acute ischemic stroke.
Time of India
02-05-2025
- Business
- Time of India
Alembic gets USFDA nod for generic drug
Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market a generic medication for the prevention of heart attack and stroke. The company has received final approval from the US Food & Drug Administration ( USFDA ) for its abbreviated new drug application (ANDA) for Ticagrelor Tablets , 90 mg and tentative approval for Ticagrelor Tablets, 60 mg, Alembic Pharma said in a statement. #Pahalgam Terrorist Attack India's Rafale-M deal may turn up the heat on Pakistan China's support for Pakistan may be all talk, no action India brings grounded choppers back in action amid LoC tensions The company's approved ANDA is therapeutically equivalent to AstraZeneca Pharmaceuticals's Brilinta Tablets, 60 mg and 90 mg, it added. Ticagrelor tablets are indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome. Play Video Pause Skip Backward Skip Forward Unmute Current Time 0:00 / Duration 0:00 Loaded : 0% 0:00 Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 1x Playback Rate Chapters Chapters Descriptions descriptions off , selected Captions captions settings , opens captions settings dialog captions off , selected Audio Track Picture-in-Picture Fullscreen This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Text Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Transparent Caption Area Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Drop shadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Villas For Sale in Dubai Might Surprise You Villas In Dubai | Search Ads Get Rates Undo For Ticagrelor Tablets, 90 mg, Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, the drug firm said. According to IQVIA, Ticagrelor Tablets (90 mg) have an estimated market size of USD 1,062 million for twelve months ending March 2025. Live Events Ticagrelor Tablets, 60 mg have an estimated market size of USD 242 million for twelve months ending March 2025. Alembic shares were trading 0.03 per cent down at Rs 876.10 apiece on BSE.
