FDA — authorised 6 February 2008
- Application: ANDA076184
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: ALENDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Fosamax in United States
FDA authorised Fosamax on 6 February 2008 · 80,919 US adverse-event reports
Marketing authorisations
FDA — authorised 4 August 2008
- Application: ANDA076768
- Marketing authorisation holder: CIPLA
- Local brand name: ALENDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 2008
- Application: ANDA090124
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ALENDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 2008
- Application: ANDA077982
- Marketing authorisation holder: APOTEX
- Local brand name: ALENDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 2008
- Application: ANDA078638
- Marketing authorisation holder: MYLAN
- Local brand name: ALENDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 2008
- Application: ANDA076584
- Marketing authorisation holder: RISING
- Local brand name: ALENDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 April 2009
- Application: ANDA075871
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ALENDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 2009
- Application: ANDA090258
- Marketing authorisation holder: HANGZHOU BINJIANG
- Local brand name: ALENDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 February 2010
- Application: ANDA090557
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: ALENDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 2013
- Application: ANDA090520
- Marketing authorisation holder: HIKMA
- Local brand name: ALENDRONATE SODIUM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 4 June 2024
- Application: ANDA206387
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: ALENDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 80,919
Most-reported reactions
- Femur Fracture — 10,184 reports (12.59%)
- Pain — 9,713 reports (12%)
- Fatigue — 8,791 reports (10.86%)
- Drug Ineffective — 8,424 reports (10.41%)
- Arthralgia — 7,754 reports (9.58%)
- Alopecia — 7,483 reports (9.25%)
- Abdominal Discomfort — 7,387 reports (9.13%)
- Rheumatoid Arthritis — 7,346 reports (9.08%)
- Systemic Lupus Erythematosus — 7,045 reports (8.71%)
- Pemphigus — 6,792 reports (8.39%)
Fosamax in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Fosamax approved in United States?
Yes. FDA authorised it on 6 February 2008; FDA authorised it on 4 August 2008; FDA authorised it on 4 August 2008.
Who is the marketing authorisation holder for Fosamax in United States?
TEVA PHARMS holds the US marketing authorisation.