Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of Forest Lab’s Tessalon®, benzonatate capsules.
Benzonatate USP capsules are therapeutically equivalent to Forest Lab’s Tessalon®, and are available in two strengths: capsules containing 100 mg and 200 mg benzonatate USP.
Benzonatate has annual sales of approximately USD 40 million in the US. Benzonatate is an antitussive, used to relieve cough due to the common cold, bronchitis, pneumonia, or other lung infections. Tessalon® is a registered trademark of Forest Laboratories, Inc.