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 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 website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.