Marksans Pharma Secures USFDA Approval for Famotidine Tablets
Marksans Pharma announced on Friday that the United States Food and Drug Administration (USFDA) has granted approval for its Abbreviated New Drug Application (ANDA) for Famotidine Tablets. The pharmaceutical company has received final approval for the Famotidine Tablets USP 10 mg and 20 mg from the US drug regulator. The tablets have been approved for over-the-counter or OTC use.
Famotidine Tablets are used to reduce acid in conditions such as acid indigestion, occasional heartburn, or sour stomach caused by eating or drinking certain foods or beverages, as well as gastroesophageal reflux disease (GERD).
The Famotidine Tablets USP, 10 mg and 20 mg, are a bioequivalent product of Pepcid AC tablets, a reference listed drug (RLD) of Johnson & Johnson Consumer Inc, which has sales of more than $200 million in the US market.
Marksans Pharma’s subsidiary Relonchem Ltd. recently received approval from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom (UK MHRA) for Fluoxetine 20 mg/5 ml oral solution, a product used in the treatment of depression.
Marksans Pharma is a global player engaged in the research, manufacturing, and marketing of generic pharmaceutical formulations, with manufacturing facilities in India, the USA, and the UK.
Shares of Marksans Pharma rose 1.63 percent higher to Rs 68.75 on Friday.
About Marksans Pharma:
Marksans Pharma is involved in the formulation of pharmaceutical products, with a primary focus on over-the-counter and prescription drugs. These drugs have a broad range of applications in various fields, such as Oncology, Gastroenterology, Antidiabetic, Antibiotics, Cardiovascular, Pain Management, Gynaecology, and more.
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