🇺🇸 SOMATROPIN in United States

FDA authorised SOMATROPIN on 25 May 1995 · 2,133 US adverse-event reports

Marketing authorisations

FDA — authorised 25 May 1995

  • Application: BLA019774
  • Marketing authorisation holder: FERRING
  • Local brand name: BIO-TROPIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 29 December 1995

  • Application: BLA020522
  • Marketing authorisation holder: GENENTECH
  • Local brand name: NUTROPIN AQ NUSPIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 23 August 1996

  • Application: BLA020604
  • Marketing authorisation holder: EMD SERONO
  • Local brand name: SEROSTIM LQ
  • Indication: INJECTABLE — SUBCUTANEOUS
  • Status: approved

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FDA — authorised 23 January 2008

  • Application: BLA021538
  • Marketing authorisation holder: EMERGENT
  • Local brand name: ACCRETROPIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Off Label Use — 403 reports (18.89%)
  2. Headache — 286 reports (13.41%)
  3. Device Leakage — 269 reports (12.61%)
  4. Injection Site Pain — 232 reports (10.88%)
  5. Drug Dose Omission By Device — 200 reports (9.38%)
  6. Fatigue — 184 reports (8.63%)
  7. Drug Ineffective — 145 reports (6.8%)
  8. Sleep Apnoea Syndrome — 142 reports (6.66%)
  9. Pyrexia — 140 reports (6.56%)
  10. Arthralgia — 132 reports (6.19%)

Source database →

SOMATROPIN in other countries

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

Frequently asked questions

Is SOMATROPIN approved in United States?

Yes. FDA authorised it on 25 May 1995; FDA authorised it on 29 December 1995; FDA authorised it on 23 August 1996.

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

FERRING holds the US marketing authorisation.