Ajanta Pharma has launched its generic Montelukast Sodium tablets used for treatment of asthma and seasonal allergies in the American market. Ajanta Pharma USA Inc, a subsidiary of the company on Thursday announced the launch of Montelukast Sodium immediate release tablets in the strength of 10mg and Montelukast Sodium chewable tablets in 4mg & 5mg strengths, Ajanta Pharma said in a filing to BSE.
The company's tablets are generic versions of Merck & Co Inc's Singulair tablets and Singulair chewable tablets respectively, it added.
The United States Food & Drug Administration (USFDA) approval is for Montelukast offerings in three dosage forms (immediate-release tablets, chewable tablets and oral granules), Ajanta Pharma said.
The company has five Abbreviated New Drug Application (ANDA) final approvals and two tentative approvals from the USFDA and 19 ANDAs are pending approval from the US health regulator, Ajanta Pharma said.
Montelukast is used for prevention and chronic treatment of asthma, prevention of exercise induced bronchoconstriction and allergic rhinitis.
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