Ajanta Pharma's Generic Anti-Asthma Chewable Tablets Approved By US FDA

Ajanta Pharma USA Inc, a subsidiary company of Ajanta Pharma Limited, India, has announced the launch of its generic Montelukast Sodium tablets in the United States.

The United Stated Food and Drug Administration (FDA) approval has extended the Montelukast Sodium tablet form into three dosage forms to be sold in the American market -- 10 mg immediate-release tablets, 4 mg and 5 mg chewable tablets and oral granules (4 mg).

The tablets launched by Ajanta Pharma are the generic version of Merck & Co Inc's Singulair tablets and Singulair chewable tablets respectively, NDTV, an Indian television news channel, reported. According to Ajanta Pharma, it has received five Abbreviated New Drug Application (ANDA) final approvals and 2 tentative approvals from the FDA. In addition, approval for 19 ANDAs are pending with the regulatory body.

According to U.S. National Library of Medicine, Montelukast is used to prevent chest tightness, difficulty in breathing and wheezing and coughing caused by asthma. In addition, it is used to prevent the symptoms associated with seasonal allergies and difficulty in breathing during exercising.

Montelukast may cause a combination of mild to severe side effects, including stomach pain, heartburn, dizziness, headache and tiredness. In case of severe side effects, patients are advised to consult their doctor.

The Centers for Disease Control and Prevention (CDC) estimated that nearly 18.7 million adult Americans currently have asthma. In addition, 6.8 million children are affected by this disease. Each year, around 3,630 individuals die because of asthma.

Ajanta Pharma Limited has its headquarters in Mumbai, India. The company develops, manufactures and markets quality finished dosages which are then exported to 35 different countries across the globe.