Lupin Receives Provisional FDA Approval for its Valbenazine Capsules

Lupin Valbenazine Capsules FDA approved

To market a generic version of Ingrezza® Capsules, 40 mg, 60 mg, and 80 mg of Neurocrine Biosciences, Inc., Lupin Limited (Lupin) today announced that its Abbreviated New Drug Application (ANDA), Valbenazine Capsules, 40 mg, 60 mg, and 80 mg, has received provisional approval from the United States Food and Drug Administration (U.S. FDA). The expected yearly sales of valbenazine capsules (RLD Ingrezza®) in the United States were USD 1,235 million (IQVIA MAT December 2022).

Valbenazine capsules are a medication used for the treatment of tardive dyskinesia, a disorder characterized by repetitive and involuntary movements of the face, tongue, and other parts of the body. Valbenazine is the active ingredient in this medication, and it works by blocking the reuptake of a neurotransmitter called dopamine in the brain. This helps to reduce the symptoms of tardive dyskinesia.

Valbenazine capsules are taken orally, typically once a day, and should be taken with food to increase absorption. The dosage may vary depending on the severity of the symptoms and other factors, and it is important to follow the instructions provided by the healthcare provider.

Like any medication, valbenazine capsules can have side effects, although not everyone will experience them. Common side effects may include drowsiness, dry mouth, headache, and constipation. It is important to inform your healthcare provider if you experience any side effects or have any concerns about taking this medication. Valbenazine capsules are available only with a prescription and should not be taken without the guidance of a healthcare provider.

More About Lupin Limited 

Lupin is a global pharmaceutical company headquartered in Mumbai, India. It was founded in 1968 by Dr. Desh Bandhu Gupta and has since grown to become one of the largest generic pharmaceutical companies in the world, with a presence in over 100 countries. Lupin specializes in the development, manufacture, and distribution of generic and branded pharmaceuticals, as well as drug delivery systems and biosimilars. The company’s product portfolio covers a wide range of therapeutic areas, including cardiovascular, central nervous system, anti-infective, and respiratory disorders, among others.

Lupin is committed to innovation and invests heavily in research and development to bring new and improved treatments to patients. The company has a number of research centers and laboratories across India and around the world, and works closely with academic institutions and other partners to advance its research efforts. In addition to its pharmaceutical business, Lupin is also active in other areas such as animal health, consumer healthcare, and specialty chemicals. The company has a strong focus on sustainability and corporate responsibility, and is committed to operating in an ethical and environmentally responsible manner.

More About FDA

The FDA, or the United States Food and Drug Administration, is a federal agency of the United States Department of Health and Human Services. It is responsible for protecting and promoting public health by regulating and supervising food safety, tobacco products, dietary supplements, prescription and over-the-counter medications, vaccines, medical devices, and other products that affect public health in the United States.

The FDA is responsible for ensuring that drugs and medical devices are safe and effective before they are approved for use by the public. This involves reviewing clinical trial data, inspecting manufacturing facilities, and evaluating labeling and advertising materials. The FDA also monitors the safety and effectiveness of these products after they are on the market, and has the authority to take action if safety concerns arise.

In addition to its regulatory functions, the FDA also provides information to the public about the safety and effectiveness of drugs and medical devices, and works with other government agencies and international organizations to promote public health and safety. The FDA plays an important role in ensuring that the products we use for our health and well-being are safe and effective. Its work helps to protect consumers and promote public health in the United States.

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