Categories: US FDA Approval

Lupin Receives FDA Approval for Potassium Chloride Extended-Release Capsules

Mumbai, August 17, 2016: Pharma Major Lupin Limited announced today that its US subsidiary, Gavis Pharmaceuticals LLC., U.S.A. (collectively Lupin) has received final approval for its Potassium Chloride Extended-Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg) from the United States Food and Drug Administration (FDA) to market a generic equivalent of Actavis Labs FL, Inc’s Potassium Chloride Extended-Release Capsules USP, 8 mEq and 10 mEq.

Lupin’s Potassium Chloride Extended-Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg) are the AB rated generic equivalent of Actavis Labs FL, Inc’s Potassium Chloride Extended-Release Capsules USP, 8 mEq and 10 mEq. It is indicated for the treatment of patients with hypokalemia, with or without metabolic alkalosis, in digitalis intoxications and in patients with hypokalemic familial periodic paralysis. It is also indicated for the prevention of hypokalemia in patients who would be at a particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

Potassium Chloride Extended-Release Capsules USP, 8 mEq and 10 mEq had US sales of USD 75.4 million (IMS MAT June 2016).

Corporate Comm India(CCI Newswire)

The Pharma Times News Bureau

Recent Posts

Esaote Group Expands Production in India

Noida, November 08, 2024: Esaote Group, a leading Italian innovator in medical imaging - ultrasound,…

7 hours ago

In Q2 FY25, AGI Greenpac Limited posts EBITDA of ₹166 crore up by 20% Y-o-Y and PAT of Rs ₹72 crore up by 28%

Gurugram, November 08, 2024: AGI Greenpac Limited, a focused Packaging Products company, today announced its financial…

7 hours ago

DKMS-BMST – Bridging the Care Gap in Blood Cancer Treatment on National Cancer Awareness Day

New Delhi, November 07, 2024: National Cancer Awareness Day serves as a poignant reminder of…

1 day ago

The Arya Vaidya Pharmacy (Coimbatore) Ltd. Strengthens Legacy with New Initiatives and Expanded Product Portfolio

Coimbatore, November 07, 2024: The Arya Vaidya Pharmacy (Coimbatore) Ltd. (AVP), a pioneer in Ayurvedic…

1 day ago

New medical nutrition ingredient combines high-protein with “best taste yet”

New Delhi, November 06, 2024: Arla Foods Ingredients has launched a new whey protein hydrolysate…

2 days ago

6 Early Signs of Ovarian Cancer

By Dr. C N Patil, HOD and Lead Consultant - Medical Oncology & Haemato-Oncology, Aster…

2 days ago