Drug firm Aurobindo Pharma has received approval from the US health regulator to manufacture and market generic Norethindrone Acetate tablets in the American market. The company has received the final nod from the US Food and Drug Administration (USFDA) to manufacture and market Norethindrone Acetate tablets in the strength of 5 mg.
The company’s product is generic version of Duramed Pharmaceuticals Aygestin tablets in the same strength. Norethindrone Acetate tablet is used in the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels and secondary amenorrhea. The company has a total of 230 abbreviated new drug application (ANDA) approvals (199 final approvals including 10 from Aurolife Pharma LLC and 31 tentative approvals) from the USFDA.
Generic Drug
- A generic drug is identical–or bioequivalent–to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
- One reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents.
- Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.
- A generic drug must contain the same active ingredients as the original formulation.
- Generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies.
