News Medical

New results reinforce COPAXONE 40 mg/mL as safe and effective for RMS patients

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced up to 7-year efficacy, safety and tolerability results from the Glatiramer Acetate Low-Frequency Administration (GALA) ...
Business Insider

Momenta Pharmaceuticals Announces FDA Approval and Launch of Glatopa® (glatiramer acetate injection) 40 mg/mL

--Glatopa 40 mg/mL is a fully substitutable, AP-rated generic version of three times-a-week COPAXONE ® (glatiramer acetate injection) 40 mg/mL for the treatment of patients with relapsing forms of ...
FiercePharma

Teva Receives Positive Outcome in Europe for Three-Times-a-Week COPAXONE® (Glatiramer Acetate) 40 mg/ml for the Treatment of Relapsing Forms of Multiple Sclerosis (RMS)

<0> Teva Pharmaceutical Industries Ltd.IR:United States, 215-591-8912, 215-591-3033orIsrael, 972 (3) 926-7656orPR:Israel, 972 (3) 926-7687orUnited States, 215-591-8974, 215-284-0213 </0> Teva ...
FierceBiotech

Teva Presents New Data Which Demonstrate Reduction of Injection-Related Adverse Events with the Less Frequent Dosing of Three-times-a-week COPAXONE® (glatiramer acetate ...

<0> Teva Pharmaceutical Industries Ltd.IR:United States 215-591-8912or215-591-3033orIsrael 972 (3) 926-7656orPR:Israel 972 (3) 926-7687orUnited States 215-591-8974or215-284-0213 </0> Teva ...
Business Insider

Mylan Confirms U.S. Launch of First Generic for Copaxone® 40 mg/mL 3-Times-a-Week and Generic for Copaxone® 20 mg/mL Once-Daily

HERTFORDSHIRE, England, and PITTSBURGH, Oct. 4, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today confirmed that the company has launched in the U.S. the first Glatiramer Acetate Injection 40 ...
Pharmabiz

Teva gets Russian marketing nod for thrice a week Copaxone 40 mg/ml for RRMS treatment

Teva Pharmaceutical Industries Ltd announced that the Russian Ministry of Health has approved the Marketing Authorisation (MA) license for three-times-a-week Copaxone (glatiramer acetate injection) 40 ...
Business Wire

Alvogen Obtains First Approval for Glatiramer Acetate 40 mg/mL in Europe

PINE BROOK, N.J.--(BUSINESS WIRE)--Alvogen today announced the successful closure of the decentralized procedure for Remurel TM (glatiramer acetate) 40 mg/mL, the first generic equivalent of Copaxone ...
The Providence Journal

Mylan's ANDA for Three Times Per Week Generic Copaxone(R) 40 mg/mL Accepted for Filing by FDA

PITTSBURGH, Aug. 28, 2014 /PRNewswire/ -- Mylan Inc. today announced that its abbreviated new drug application (ANDA) for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted ...
Nasdaq

Mylan, Synthon Win European Patent Office Ruling Related To Copaxone 40 Mg/ML

(RTTNews) - Mylan N.V. (MYL) said Tuesday that the company and development partner Synthon has won a significant European Patent Office ruling related to Copaxone 40 mg/mL. According to Mylan, the ...
PharmiWeb

Mylan, in Partnership with Synthon, Receives Marketing Authorization Approval in Europe for First Generic for Copaxone® 40 mg/mL

Mylan N.V. (NASDAQ, TASE: MYL) today announced that partner, Synthon, received marketing authorization approval in Europe for Glatiramer Acetate Injection 40 mg/mL, a therapeutically equivalent ...
The Financial

Teva Announces Approval of Three-Times-A-Week COPAXONE 40 mg/mL in Russia

The FINANCIAL — Teva Pharmaceutical Industries Ltd. on October 8 announced that the Russian Ministry of Health has approved the Marketing Authorization license (MA) for three-times-a-week COPAXONE ...
FiercePharma

Teva Receives Positive Outcome in Europe for Three-Times-a-Week COPAXONE® (Glatiramer Acetate) 40 mg/ml for the Treatment of Relapsing Forms of Multiple Sclerosis (RMS)

MHRA and other EU Member States Issue Positive Assessment Report under the Decentralized Procedure for New, Three-Times-A-Week COPAXONE® 40 mg/ml Formulation The three-times-a-week COPAXONE® 40 mg/ml ...