Generic Forms of Rogaine Get FDA Approval

Trying to get rid of that bald spot may get cheaper yet.

The Food and Drug Administration has given permission to two companies to sell generic nonprescription versions of Rogaine, the hair-regrowth solution.

The decision by the FDA, announced Monday, comes two months after it gave Rogaine’s maker, Pharmacia & Upjohn Inc., permission to sell topical minoxidil without a prescription. The suggested retail price for prescription Rogaine was about $60 for a one-month supply; the price for the nonprescription version is about $35.

In approving the generic versions by Alpharma Inc. and Lemmon Co., the FDA rejected Pharmacia’s petition for a three-year monopoly on the product--something usually granted when a product is converted for over-the-counter use.

Under federal law, drug companies can petition the FDA for the monopoly if they pay for new research required when a company wants to convert a prescription drug for nonprescription use. Such petitions are usually approved, but in this case the FDA said Pharmacia failed to meet criteria.

Generics, which are supposed to be medically equivalent to brand-name products, typically retail for 25% to 50% less. The decision means consumers will be able to buy generic minoxidil for much less than Pharmacia’s suggested price.

Pharmacia said Monday that it is outraged by the FDA decision, contending that the agency has not followed federal law.

“Our effort to bring [over-the-counter] Rogaine to market spanned five years and required an investment of millions of dollars,” Pharmacia spokesman Jeffrey Palmer said. He said the company conducted numerous studies to prove the drug is safe and that consumers could use it without guidance from a doctor. He said Pharmacia may pursue legal action, but he would not elaborate.

An FDA spokeswoman refused to elaborate on the reasons Pharmacia’s request was rejected.