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Perrigo (PRGO) Gets FDA Nod for First OTC Birth Control Pill

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Perrigo Company plc (PRGO - Free Report) announced that the FDA approved its regulatory filing seeking to make Opill, a progestin-only daily birth control pill, available as an over-the-counter (“OTC”) drug.

Following approval, Perrigo’s Opill is the first-ever daily birth control pill made available OTC without a prescription in the United States. The drug is expected to be made available in online and offline stores in the country early next year during the first quarter.

The removal of a prescription requirement for Opill would help American women get easy access to a contraceptive method that is more effective at preventing pregnancy than all current OTC methods.

Though contraceptives like Opill have been available for decades, their demand is likely to increase following the overturning of the Roe v. Wade decision by the U.S. Supreme Court last year. Consequently, abortion is illegal in most states in the country.

Management estimates that 45% of the six million yearly pregnancies in the United States are unintended. In fact, around one-third of American women who had ever tried to obtain a prescription or refill for birth control products, including the pill, had faced difficulties in doing so.

Shares of Perrigo have lost 2.5% so far this year against the industry’s 4.2% growth.

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The FDA’s approval was expected as a joint committee meeting of the FDA’s Nonprescription Drugs Advisory Committee (“NDAC”) and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (“ORUDAC”) was held earlier in May, which unanimously recommended making Opill available as an OTC drug.

Owing to abortions becoming illegal, the demand for birth control pills is likely to increase in the upcoming days as these are safe for most women to use. Though not a substitute for abortions, birth control pills do help prevent pregnancy.

Increasing easy access to an OTC birth control pill will likely provide women with better control of their reproductive life without facing unnecessary barriers. Approval of non-prescription birth control pills has been advocated by health experts for some time. They feel these pills should be available easily over the counter. An approval of Opill as an OTC drug will likely increase the demand for the drug but, at the same time, may also help Perrigo in generating additional product revenues from the drug’s sales.

 

Zacks Rank & Other Stocks to Consider

Perrigo carries a Zacks Rank #2 (Buy) at present. Some other top-ranked stocks in the overall healthcare sector include Alkermes (ALKS - Free Report) , Axsome Therapeutics (AXSM - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for Alkermes’ 2023 earnings have increased from 20 cents to 79 cents in the past 60 days. The earnings estimates for 2024 have also increased from $1.73 to $2.07 in the past 60 days. Shares of Alkermes have risen 14.9% in the year-to-date period.

Earnings of Alkermes beat estimates in three of the last four quarters and met the mark on the one occasion, the average surprise being 90.83%. In the last reported quarter, Alkermes delivered an earnings surprise of 133.33%.

Estimates for Axsome Therapeutics’ 2023 earnings have narrowed from $4.16 to $3.96 in the past 60 days. The loss estimates for 2024 have also improved from $1.65 to $1.63 in the past 60 days. Shares of Axsome have lost 5.4% in the year-to-date period.

Earnings of Axsome Therapeutics beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 22.34%. In the last reported quarter, Axsome delivered an earnings surprise of 80.53%.

In the past 60 days, the estimate for Ligand’s 2023 earnings per share has increased from $4.79 to $5.25. During the same period, the earnings per share estimate for 2024 has increased from $4.58 to $4.69. So far this year, the shares of Ligand have risen 2.5%.

Ligand Pharmaceuticals beat earnings estimates in two of the last four quarters and missed the mark on the other two occasions. On average, the company’s earnings witnessed an earnings surprise of 21.50%.In the last reported quarter, Ligand delivered an earnings surprise of 121.36%.

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