Aurobindo Pharma receives USFDA nod for endometriosis treatment drug
New Delhi: 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, Aurobindo Pharma said in a statement.
"The approved product has an estimated market size of USD 24 million for the 12 months ending November 2015 according to IMS," it added.
The company's product is generic version of Duramed Pharmaceuticals Aygestin tablets in the same strength, Aurobindo Pharma said.
"Norethindrone Acetate tablet is used in the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels and secondary amenorrhea," it added.
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.
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, Aurobindo Pharma said in a statement.
"The approved product has an estimated market size of USD 24 million for the 12 months ending November 2015 according to IMS," it added.
The company's product is generic version of Duramed Pharmaceuticals Aygestin tablets in the same strength, Aurobindo Pharma said.
"Norethindrone Acetate tablet is used in the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels and secondary amenorrhea," it added.
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.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd