When was atropine FDA approved?: A Historical Look at a Versatile Medication

October 10, 2025 •

3 min read

The initial U.S. approval for certain uses of atropine sulfate was granted in 1960. However, the long and complex history of atropine's medical use and FDA regulation means the answer to the question, "When was atropine FDA approved?" depends on the specific formulation and indication.

Quick Summary

The first U.S. FDA approval for atropine sulfate was in 1960. Subsequent approvals followed for different formulations, including the Atropen autoinjector in 1973 and various ophthalmic solutions throughout the 2000s and 2010s.

Key Points

Initial Approval: The first U.S. FDA approval for atropine sulfate for certain uses was in 1960.
Multiple Forms: Separate FDA approvals were granted for different formulations, such as injections and autoinjectors.
Atropen Autoinjector: The Atropen autoinjector for adults was approved in 1973, with a pediatric version following in 2003.
Ophthalmic Regulation: Ophthalmic solutions were initially marketed as "grandfathered" products before receiving formal FDA approval in 2014.
Ongoing Innovation: New low-dose atropine formulations are currently under review for emerging indications like pediatric myopia.
Versatile Uses: Atropine's FDA approvals cover a range of applications, from antidotes for poisoning to ophthalmic procedures and cardiology.
Timeline Complexity: The drug's long history means there is no single FDA approval date, but rather a series of approvals over decades.

Initial Systemic Approval in 1960

The story of atropine's FDA journey begins in 1960, when atropine sulfate was first approved for prescription use in the United States. This initial approval covered systemic forms of the drug, primarily injections, which were indicated for severe or life-threatening muscarinic effects. It is a muscarinic antagonist, meaning it blocks the muscarinic-like actions of acetylcholine, a neurotransmitter, impacting the parasympathetic nervous system. This made it a vital tool for a variety of conditions, including bradyasystolic cardiac arrest, as well as an antidote for certain types of poisoning.

The Evolution of Atropine Approvals

Atropine's history is not a single, linear story of one approval. Different formulations, applications, and manufacturers have sought and received FDA approval over many decades, creating a complex timeline. While the systemic forms were approved early, other applications, particularly for ophthalmology, have a more nuanced regulatory background.

The "Grandfathered" Generation

Before modern drug regulations, some products were marketed without formal FDA approval, a status known as "grandfathered". The ophthalmic solution of atropine sulfate is a prime example. For many years, atropine 1% ophthalmic solution was on the market as an unapproved product, with some manufacturers producing it as far back as the mid-1990s. This changed with modern regulatory requirements, which eventually led to formal approvals for specific ophthalmic products.

The Atropen Autoinjector

The Atropen (atropine autoinjector) has its own distinct approval history, tied to its use as an antidote. The FDA approved the autoinjector for use in adults exposed to certain nerve agents or insecticides in 1973. In 2003, the FDA approved new dosage forms of the Atropen specifically for children and adolescents, expanding its use as a countermeasure against potential terrorist attacks or accidental poisonings.

Formal Ophthalmic Approvals

The pathway for ophthalmic atropine moved toward formal approval in the 21st century. For example, Atropine Sulfate Ophthalmic Solution, USP 1%, which is used to produce cycloplegia (paralysis of the ciliary muscle) and mydriasis (pupil dilation), received its first formal FDA approval in 2014, although unapproved versions had been in use for over a century.

Comparison of Atropine Approvals


Product/Formulation	Initial Approval Date	Key Indication	Status Notes
Atropine Sulfate Injection	1960	Severe muscarinic effects, cardiac arrest, poisoning	Original approval for systemic use
Atropen Autoinjector (Adult)	1973	Nerve agent or insecticide poisoning	Specifically for emergency field use
Atropen Autoinjector (Pediatric)	2003	Nerve agent or insecticide poisoning in children	Expands use to a wider population
Atropine Sulfate Ophthalmic Solution 1%	2014	Mydriasis, cycloplegia, amblyopia treatment	Formal approval for a long-marketed "grandfathered" product
Atropine Sulfate Injection, USP (Manufacturer Specific)	2022	Blockade of muscarinic effects, poisoning	New approval for a specific manufacturer's generic injectable

Recent Developments and Future Approvals

Innovation in atropine formulations continues, with recent attention focused on lower-dose eye drops for the management of pediatric myopia (nearsightedness). While these ultra-low-dose formulations have been available through compounding pharmacies, a formal FDA approval would standardize the product and allow for wider prescription use. In March 2025, the FDA accepted a New Drug Application (NDA) for a low-dose atropine formulation from Sydnexis for myopia management, with a target action date set for October 2025. This potential approval highlights how even older, well-known drugs can find new applications and undergo the regulatory process again.

Conclusion

The FDA approval timeline for atropine is a story of a single, ancient compound finding numerous applications over time, each requiring its own regulatory pathway. From the initial systemic approvals in 1960 to modern, specialized formulations for conditions like pediatric myopia, atropine’s regulatory history demonstrates the evolution of drug safety and efficacy standards. The simple question, "When was atropine FDA approved?" reveals a complex tapestry of regulatory milestones spanning over half a century, with each approval adding another chapter to the drug's long and important medical history. Understanding this history is crucial for appreciating the different therapeutic uses of atropine and the rigorous process drugs undergo to reach patients safely. For more information on drug regulation, visit the FDA's official website.

Frequently Asked Questions

The initial U.S. FDA approval for atropine sulfate for prescription use was in 1960.

The Atropen autoinjector for adults was approved in 1973, with a new version for children and adolescents receiving approval in 2003.

No, atropine ophthalmic solution was available for many years as a "grandfathered" product before receiving formal FDA approval in 2014.

Different approval dates exist because each specific formulation, dosage form, and indication of atropine had to undergo its own separate FDA review process.

The 1960 approval only covers the specific products approved at that time. Other products, like the Atropen autoinjector and newer ophthalmic solutions, received their own distinct approvals much later.

Yes, in March 2025, the FDA accepted an NDA for a new low-dose atropine drop for pediatric myopia, with a target decision date in late 2025.

Atropine is used for various purposes, including as an antidote for certain poisonings, to dilate pupils during eye exams, and to treat certain cardiac conditions like bradycardia.