Last Updated on December 31, 2023 by The Health Master
Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) nifedipine extended-release tablets (USP), 30 mg, 60 mg, and 90 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Procardia XL extended-release tablets, 30 mg, 60 mg, and 90 mg, of Pfizer Inc. nifedipine extended-release tablets, are indicated for the management of:
- i) vasospastic angina
- ii) chronic stable angina (classical effort-associated angina)
- iii) hypertension.
According to IQVIA, the market for nifedipine extended-release tablets (USP), 30 mg, 60 mg, and 90 mg, is worth US$ 56 million in the year ending September 2022.
Alembic has a cumulative total of 177 ANDA approvals (153 final approvals and 24 tentative approvals) from the USFDA.
USFDA gives nod for Amphotericin B Liposome Injection
USFDA gives approval for Potassium-deficiency drug
USFDA gives final approval for Cyclophosphamide capsules
USFDA gives nod to market this generic Antibiotic Drug
USFDA gives tentative approval for Drospirenone tablets
USFDA approves Ketorolac Tromethamine injection
NPPA: No bar on taking corrective measures if some error occurs
RIICO to develop Medical Devices Park
USFDA gives nod for Amphotericin B Liposome Injection
USFDA issues Form 483 with 10 observations to Aurobindo Pharma
USFDA gives approval for Potassium-deficiency drug
Govt starts drive against misuse of Antibiotics
Bar code or QR code for 300 brands: Govt notifies these drugs under Schedule H2
USFDA gives EIR to Aurobindo Pharma for its AP facility
Maha FDA to take action against bodybuilders involved in misuse of prescription drugs
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
