USFDA Green Light! Alembic Pharma Scores Huge Approval for Key Heart Medication

Author

Simar Singh | Whalesbook News Team

Detailed Coverage:

Alembic Pharmaceuticals Limited announced on November 15 that it has secured final approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA). The approved product is Diltiazem Hydrochloride Tablets USP, available in 30 mg, 60 mg, 90 mg, and 120 mg strengths. These tablets are prescribed for treating high blood pressure and angina, a type of chest pain. The approved ANDA is considered therapeutically equivalent to Cardizem Tablets, the reference listed drug (RLD) manufactured by Bausch Health US, LLC. This approval adds to Alembic Pharmaceuticals' significant track record, bringing their cumulative total of ANDA approvals from the USFDA to 230, which includes 210 final approvals and 20 tentative approvals.

Impact This USFDA approval is a significant positive development for Alembic Pharmaceuticals. It allows the company to market and sell its Diltiazem Hydrochloride Tablets in the highly lucrative United States market. Successful commercialization of this generic drug is expected to contribute to the company's revenue stream and profitability, further strengthening its position in the global pharmaceutical market. The consistent stream of USFDA approvals highlights the company's robust research and development capabilities and its adherence to stringent quality standards. Rating: 6/10

Difficult Terms: Abbreviated New Drug Application (ANDA): An application submitted to the USFDA for approval to market a generic drug that has already been approved by the FDA. It demonstrates that the generic drug is the same as a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. US Food & Drug Administration (USFDA): A federal agency of the Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation. USP (United States Pharmacopeia): A compendium of standards for medication identity, strength, quality, and purity that are enforceable in the United States. When applied to a drug, it means the drug meets these official standards. Angina: Chest pain or discomfort caused when your heart muscle doesn't get enough oxygen-rich blood. Therapeutically Equivalent: Pharmaceutical products are considered therapeutically equivalent if they are pharmaceutically equivalent and if bioequivalence is demonstrated, they will provide the same clinical effect and safety.