Press release

FDA Approves Supplemental New Drug Application for Veltassa® Removing Boxed Warning Regarding Drug-Drug Interactions

Monday, 28 November 2016, ↓ directly to download

FDA Approves Supplemental New Drug Application for Veltassa® Removing Boxed Warning Regarding Drug-Drug Interactions

- The updated US label for Veltassa® recommends patients take Veltassa® at least 3 hours before or 3 hours after other oral medications
- Change can provide doctors greater flexibility in prescribing Veltassa® to patients
- Approval reinforces potential of Veltassa® as a key platform of additional growth for Vifor Pharma
- Vifor Pharma to make necessary investments to achieve Veltassa’s significant mid-term potential


Galenica Group today announced that Relypsa, Inc., a Vifor Pharma Company, has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) with important updates to the US label of Veltassa® (patiromer) for oral suspension. The US label for Veltassa® no longer includes a Boxed Warning regarding the separation of Veltassa® and other oral medications.

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Galenica is a diversified Group active throughout the healthcare market which, among other activities, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. With its two Business units Vifor Pharma and Galenica Santé, the Galenica Group enjoys a leading position in all its core business activities. A large part of the Group’s income is generated by international operations. Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646).

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Christina Hertig

Christina Hertig

Head of Corporate Communications


Galenica Ltd.

Corp. Communications
Untermattweg 8
CH-3027 Bern

Phone:
+41 58 852 85 17
Fax:
+41 58 852 85 58

Julien Vignot

Julien Vignot

Head Investor Relations


Galenica Ltd.

Investor Relations
Untermattweg 8
CH-3027 Bern

Phone:
+41 58 852 81 11
Fax:
+41 58 852 81 12

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