Printer Friendly

Impax passes US FDA approval for generic Adderall XR Capsules.

M2 EQUITYBITES-February 18, 2016-Impax passes US FDA approval for generic Adderall XR Capsules

(C)2016 M2 COMMUNICATIONS http://www.m2.com

Specialist pharmaceutical company Impax Laboratories (NasdaqGS:IPXL) reported on Wednesday that it has received US Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (mixed salts of a single-entity amphetamine product) extended-release capsules, CII, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg.

This mixed amphetamine is the generic version of Adderall XR (mixed salts of a single-entity amphetamine product) Capsules, CII, added the company.

For the 12 months ending November 2015, the US brand and generic sales of mixed amphetamine sales capsules, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg were approximately USD1.8bn, according to IMS Health (NSP).

The company said dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, are indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

((Comments on this story may be sent to info@m2.com))

COPYRIGHT 2016 Normans Media Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2016 Gale, Cengage Learning. All rights reserved.

 
Article Details
Printer friendly Cite/link Email Feedback
Publication:M2 EquityBites (EQB)
Date:Feb 18, 2016
Words:185
Previous Article:Aviat announces USD2.9m project deal with Northeast US utility.
Next Article:SYNNEX Corporation and Aerohive sign exclusive distributor agreement for US and Canada.
Topics:

Terms of use | Privacy policy | Copyright © 2018 Farlex, Inc. | Feedback | For webmasters