Back in March of 2010, the FDA ordered manufacturers to remove nitroglycerin sublingual tablets (the generic for Nitrostat) from the market until it received official approval. Since nitroglycerin sublingual tablets were produced before the Food, Drug, and Cosmetic Act of 1938 (which required pre-market approval for drugs based on their safety), it had never gone through an official approval process, until now!
You can learn more about this approval here.
What are nitroglycerin sublingual tablets used for?
Nitroglycerin sublingual tablets are prescribed for the immediate relief of chest pain. Most people take them before any physical activity.
How do I take them?
This medication is meant to be taken sublingually, which means “under the tongue.” They can also be dissolved in the cheek, known as buccal administration.
Nitroglycerin should not be chewed, crushed, or swallowed.
It is very important that you monitor your pain when using nitroglycerin sublingual tablets. If after 5 minutes you still have no pain relief, you should call 911 immediately. You may then take up to 2 more doses spaced out from each other by 5 minutes, while waiting for the ambulance to arrive.
What strengths of nitroglycerin sublingual tablets will be available?
Nitroglycerin tablets will be available in the same strengths as the name brand Nitrostat, 0.3mg, 0.4mg, and 0.6mg.
What companies will be making nitroglycerin sublingual tablets?
Dr Reddy’s and Greenstone LLC are the generic manufacturing companies bringing their versions of nitroglycerin sublingual tablets to the market.
Greenstone’s nitroglycerin tablets will be the authorized generic equivalent to Nitrostat, meaning that the product has the same active and inactive ingredients, and look similar to the brand name medication.
On the other hand, Dr Reddy’s tablets will be therapeutically equivalent. This means that it contains the same active ingredients, but may have different inactive ingredients.
Both of these manufacturer’s nitroglycerin tablets have undergone vigorous testing by the FDA to ensure their safety!