🇺🇸 Pivamdinocillin in United States

FDA authorised Pivamdinocillin on 24 April 2024

Marketing authorisation

FDA — authorised 24 April 2024

  • Application: NDA216483
  • Marketing authorisation holder: ALEMBIC THERAP
  • Local brand name: PIVYA
  • Indication: TABLET — ORAL
  • Status: approved

The FDA approved Pivamdinocillin, a new active ingredient, for marketing in the United States on 24 April 2024. The approval was granted to ALEMBIC THERAP under the standard expedited pathway. Pivamdinocillin is intended for the treatment of a specific medical condition, but the exact indication is not specified in the available information.

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Pivamdinocillin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in United States

Frequently asked questions

Is Pivamdinocillin approved in United States?

Yes. FDA authorised it on 24 April 2024.

Who is the marketing authorisation holder for Pivamdinocillin in United States?

ALEMBIC THERAP holds the US marketing authorisation.