"The US Food and Drug Administration's (FDA's) Arthritis Drugs Advisory Committee gave its backing to CT-P13, a drug that would be the first biosimilar monoclonal antibody approved in the United States.
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DOSAGE AND ADMINISTRATION
The recommended dose of cevimeline hydrochloride is 30 mg taken three times a day. There is insufficient safety information to support doses greater than 30 mg tid. There is also insufficient evidence for additional efficacy of cevimeline hydrochloride at doses greater than 30 mg tid.
EVOXAC (cevimeline hcl) ® is available as white, hard gelatin capsules containing 30 mg of cevimeline hydrochloride. EVOXAC® capsules (cevimeline hcl) have a white opaque cap and a white opaque body. The capsules are imprinted with "EVOXAC (cevimeline hcl) " on the cap and"30 mg" on the body with a black bar above "30 mg". It is supplied in child resistant bottles of:
100 capsules (NDC 63395-201-13)
Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F)
Norman, OK 73072 Distributed and Marketed by: Daiichi Pharmaceutical Corporation Montvale, NJ 07645
EVOXAC (cevimeline hcl) is a registered trademark of Daiichi Pharmaceutical Co., Ltd.
PRT38A Revised 05/2006 Printed in U.S.A. FDA revision date: 12/13/06
Last reviewed on RxList: 2/8/2017
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