FDA clears Aurobindo’s Rizatriptan Benzoate orally disintegrating tablets

New Drug Approvals

India-based Aurobindo Pharma has obtained final FDA approvals to manufacture and market Rizatriptan Benzoate orally disintegrating tablets (ODT) 5mg and 10mg (ANDA 203062)…




Rizatriptan (trade name Maxalt) is a 5-HT1 agonist triptan drug developed by Merck & Co. for the treatment of migraine headaches. It is available in strengths of 5 and 10 mg as tablets and orally disintegrating tablets (Maxalt-MLT).

Maxalt obtained approval by the United States Food and Drug Administration (FDA) on June 29, 1998. It is a second-generation triptan.

Rizatriptan is available only by prescription in Australia, the United StatesCanada andNew Zealand. Similarly, it is classed as a POM (Prescription Only Medicine) in the United KingdomItaly (as Rizaliv), Israel (as Rizalt), The NetherlandsCroatia and Spain (asMaxalt)

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