FDA Concerns About Therapeutic Equivalence with Two Generic Versions of Concerta Tablets
Based on an analysis of data, FDA has concerns about whether or not two approved generic versions of Concerta tablets (methylphenidate hydrochloride extended-release tablets), used to treat attention-deficit hyperactivity disorder in adults and children, are therapeutically equivalent to the brand-name drug. The two approved generic versions of Concerta are manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd.
FDA has not identified any serious safety concerns with these two generic products.
FDA’s Scientific Evaluation of Generic Concerta Products
An analysis of adverse event reports, an internal FDA re-examination of previously submitted data, and FDA laboratory tests of products manufactured by Mallinckrodt and Kudco have raised concerns that the products may not produce the same therapeutic benefits for some patients as the brand-name product, Concerta, manufactured by Janssen Pharmaceuticals, Inc. Janssen also manufactures an authorised Concerta generic, which is marketed by Actavis under a licensing agreement and is identical to Janssen’s Concerta. FDA included the authorised generic in its analysis and found it to be bioequivalent to, and substitutable for, Concerta. Apart from the Mallinckrodt, Kudco, and Actavis products, there are no other generics for Concerta.
Methylphenidate hydrochloride extended-release products approved as generics for Concerta are intended to release the drug in the body over a period of 10 to 12 hours. This should allow for a single-dose product that is consistent with the effect of a three times per day dose of immediate-release methylphenidate hydrochloride.
In some individuals, the Mallinckrodt and Kudco products may deliver drug in the body at a slower rate during the 7- to 12-hour range. The diminished release rate may result in patients not having the desired effect.
As a result, the FDA has changed the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products from AB to BX. This means the Mallinckrodt and Kudco products are still approved and can be prescribed, but are no longer recommended as automatically substitutable at the pharmacy (or by a pharmacist) for Concerta.
Consequently, FDA has revised its draft guidance for industry for bioequivalence testing for methylphenidate hydrochloride extended-release tablets (Concerta). FDA has asked that within 6 months, Mallinckrodt and Kudco confirm the bioequivalence of their products using the revised bioequivalence standards, or voluntarily withdraw their products from the market.
FDA will continue to evaluate its testing and approval standards and bioequivalence guidances for other generic methylphenidate hydrochloride extended-release products and revise as needed.
Related News
-
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
News Eisai Alzheimer’s drug authorised in UK but still faces obstacles
In partnership with BioArctic AB, pharmaceutical company Eisai has been granted Marketing Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) for its Alzheimer’s disease drug product Leqembi. -
News Eli Lilly's weight loss drugs removed from the FDA's shortage list
The US FDA have recently updated their drug shortage list. The recently released list shows that all dosage forms of Eli Lilly's weight-loss drug Zepbound and their diabetes drug Mounjaro are now available. -
News Global advancements in the diagnosis and treatment of rare diseases: Rare Disease Day 2024
Rare Diseases Day is celebrated on the 29th February 2024 and represents the plight of rare disease patients to gain diagnosis and access to suitable treatment. -
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA).
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance