Alembic Pharma gets USFDA nod for insomnia treatment drug

Published On 2018-11-29 10:55 GMT   |   Update On 2018-11-29 10:55 GMT

Drug firm Alembic Pharmaceuticals has received approval from the US health regulator for Temazepam capsules, used for the treatment of insomnia.


The company has got approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 7.5mg, 15mg, 22.5mg and 40mg, Alembic Pharmaceuticals said in a BSE filing.


The approved abbreviated new drug application (ANDA) is the therapeutic equivalent to the reference listed drug product (RLD) Restoril Capsules.




Quoting IQVIA sales data, the company said, Temazepam capsules 7.5mg, 15mg, 22.5mg and 40mg had an estimated market size of USD 48 million for 12 months, ending December 2017.

Article Source : PTI

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 or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

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 .

Similar News