The U.S. Food and Drug Administration (FDA) has notified Lannett Co. Inc. that the agency intends to withdraw its approval of generic versions of the company’s drugs used to treat attention deficit hyperactivity disorder or ADHD. According to a news report in the Philadelphia Business Journal, the product in question is the generic version of Concerta. The drug Concerta has recently been under a great deal of scrutiny due to evidence that it causes and increased risk of intense suicidal thoughts, especially in children, adolescents, and young adults. Due to the serious nature of these side effects, the number of Concerta lawsuits is expected to grow.
Why Does the FDA Plan to Withdraw Approval?
The FDA’s decision to withdraw approval of generic forms of Concerta came after patients reported that the benefits of the generic tablets would wear off much faster than those provided by the brand-name version. The FDA further explained that the withdrawal relates to the steps the agency first took in 2014 when it expressed concerns about the therapeutic effects of the generic Concerta products. At that time, the companies making the generic tablets were given six months to provide data and evidence in support of the products’ effectiveness.
FDA officials claim the data submitted by one of the companies was insufficient and that the other company did not submit any additional data. Neither of the companies followed the agency’s request to voluntarily withdraw the products. The makers of generic Concerta now have until November 17th to request a hearing or appeal. Lannett’s CEO has issued a statement that their products are safe and effective and that they are in the process of compiling more evidence to convince the FDA that their drugs offer patients a cheaper and safer option.
Drugs That Don’t Meet Treatment Needs
Medications that don’t work the way they are intended to work can have adverse effects and pose a safety risk to patient. A generic drug may be a cheaper alternative to the brand-name medications, which are often twice as costly. However, if the generic drug does not do what the brand-name drug does and achieve the same measure of efficacy, then it is of no use to consumers. Furthermore, an ineffectively treated medical or psychiatric condition may have serious consequences for patients and their loved ones.
Contact an Experienced Concerta Lawyer
If you or a loved one has been injured as a result of taking the ADHD medication Concerta, you may be able to receive compensation for your medical bills, lost income and pain and suffering, among other losses. Our firm is working with experienced Concerta lawyers across the country, who are investigating these cases. They may be able to file a lawsuit for you, and they charge no fee unless you win an award or settlement. For a free (no obligation) case evaluation, call our toll free number at 1-800-992-6878 or fill out a contact form online.