Homegrown pharmaceutical giant Alembic Pharma today announced that it had received the USFDA’s nod for its new anti-influenza drug. The Amantadine Hydrochloride USP, 100 mg, capsules are used to treat symptoms of infections caused or exacerbated by the influenza virus. With this addition, Alembic Pharma now has 58 Abbreviated New Drug Application (ANDA) approvals.
The United States Food and Drug Administration (USFDA) is the United States’s governmental authority and the final deciding body over which drugs will receive approval for sale in the country and which ones will get rejected.
Amantadine Hydrochloride capsules have been found to be very effective in the “treatment of signs and symptoms of infection caused by various strains of influenza A virus”, the company said in a statement.
The Influenza A virus is commonly known as the Flu and it is seen every year in global pandemics in what is called the “Flu season.”. It results in about three to five million cases of severe illness every year besides 250,000 to 500,000 deaths, WHO figures say. Deaths mostly occur in the young, the infirm and in those who have some related illness.
Alembic‘s newly approved ANDA is the medical equivalent to the commonly available Symmetrel capsules, 100mg, manufactured byEndo Pharmaceuticals, Inc.
Amantadine hydrochloride capsules are also said to be of use in the management and the treatment of signs and symptoms of infection caused by varied strains of the Influenza A virus. Besides, the same capsules also have some role to play in the prophylaxis and treatment of Parkinsonism and drug-induced extrapyramidal reactions.
Many compound drugs have the effect of prophylaxis in other, unrelated diseases as well.
Alembic Pharma is based out of Vadodara city of Gujarat and is involved in the manufacture of various pharmaceutical products, pharmaceutical substances as well as intermediates. In India, Alembic is the market leader in the macrolides segment of anti-infective drugs.