Aurobindo Pharma gets USFDA nod for generic osteoporosis drug
New Delhi, Aug 29 : Aurobindo Pharma today said it has received approval from the US FDA to manufacture and market its generic version of Eli Lilly's Evista tablets used to treat and prevent osteoporosis in postmenopausal women.The approval by the USFDA for Raloxifene Hydrochloride tablets is for strength of 60 mg, which is bio and therapeutically equivalent to the reference listed drug...
Login or Register to read the full article
New Delhi, Aug 29 : Aurobindo Pharma today said it has received approval from the US FDA to manufacture and market its generic version of Eli Lilly's Evista tablets used to treat and prevent osteoporosis in postmenopausal women.
The approval by the USFDA for Raloxifene Hydrochloride tablets is for strength of 60 mg, which is bio and therapeutically equivalent to the reference listed drug product (RLD) Evista, 60 mg of Eli Lilly, the company said in a statement.
The product has an estimated market size of USD 404 million for the 12 months ended June 2015, the company added, citing IMS data.
This is the 45th Abbreviated New Drug Application (ANDA) to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products.
Aurobindo Pharma now has a total of 210 ANDA approvals, 182 final ones, including 9 from Aurolife Pharma LLC and 28 tentative approvals from USFDA, it added.
The approval by the USFDA for Raloxifene Hydrochloride tablets is for strength of 60 mg, which is bio and therapeutically equivalent to the reference listed drug product (RLD) Evista, 60 mg of Eli Lilly, the company said in a statement.
The product has an estimated market size of USD 404 million for the 12 months ended June 2015, the company added, citing IMS data.
This is the 45th Abbreviated New Drug Application (ANDA) to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products.
Aurobindo Pharma now has a total of 210 ANDA approvals, 182 final ones, including 9 from Aurolife Pharma LLC and 28 tentative approvals from USFDA, it added.
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