Alembic Pharmaceuticals said on Thursday that the U.S. Food and Drug Administration (FDA) has given its approval for the company to commercialize a generic version of a drug used to treat illnesses brought on by parasitic worms. Alembic’s Abbreviated New Drug Application (ANDA) for Albendazole Tablets USP (200 mg) has been approved. The branded medication Albenza tablets from Impax Laboratories, Inc. is therapeutically identical to this generic formulation.
An antiparasitic drug called albendazole is frequently used to treat a variety of infections brought on by parasitic worms. The medication works especially well against the following two serious conditions:
- Parenchymal Neurocysticercosis: Taenia sodium, the pig tapeworm, is the larval stage that causes this illness. When the larvae infiltrate the brain and surrounding tissues, neurocysticercosis develops, resulting in neurological symptoms and perhaps serious health problems. Albendazole treats the infection and lessens symptoms by assisting the body in getting rid of the larvae.
- Cystic Hydatid Disease : Echinococcus granuloses, the larval form of the canine tapeworm, is the cause of this illness. It usually affects the peritoneum, or lining of the abdominal cavity, the liver, and the lungs. It can result in cysts that cause pain, organ failure, and other consequences. Albendazole relieves the symptoms of the condition by specifically targeting and eliminating the cysts.
The authorization granted to Alembic to distribute this generic form of albendazole signifies a significant advancement in the pharmaceutical industry. Patients have more access to necessary therapies thanks to generic pharmaceuticals’ affordable substitute for branded ones. Alembic Pharmaceuticals hopes to lower the total cost of medication while providing patients with more treatment alternatives for these severe parasite diseases by providing a therapeutically similar form of Albenza.
With the FDA’s approval, Alembic’s albendazole tablets can now be used to treat the listed conditions since they satisfy the necessary requirements for safety, effectiveness, and quality. Alembic Pharmaceuticals has accomplished a great deal with this approval, demonstrating its dedication to growing its product line and improving public health by giving reasonably priced treatment options.
SOURCE:
ECONOMIC TIMES
