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Sept 12 (Reuters) – Perrigo Co Plc said on Monday that the U.S. Food and Drug Administration had scheduled a meeting of external experts on Nov. 18 to review the application of its daily birth control pill for over-the-counter (OTC) use.

The drugmaker’s unit, HRA Pharma, in July submitted an application to the health regulator seeking to make its clomid no prescription contraceptive drug, Opill, an over-the-counter pill.

Since the U.S. Supreme Court’s decision in June to overturn the 1973 Roe v. Wade case that legalized abortion nationwide, the spotlight has been on contraception access.

Abortion rights activists have stepped up calls to make mifepristone, which, in combination with misoprostol, induces an abortion up to 10 weeks into a pregnancy, available without a clomid no prescription.

Opill, a non-estrogen contraceptive, has been used with prescription since its approval in 1973. If the FDA approves HRA Pharma’s application, Opill would become the first daily OTC birth-control pill in the United States.

HRA said in July it was expecting a decision from the FDA in the first half of 2023.

(Reporting by Bhanvi Satija in Bengaluru; Editing by Anil D’Silva)

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April 4 (Reuters) – The London Metal Exchange said on Monday it would commission an independent review into the events that led to chaos in the nickel market last month, and cheap clomid without insurance said it had introduced daily price limits for all its metals.

The LME, the world’s oldest and largest market for industrial metals, last month brought in 15% upper and cost of clomid without prescription lower daily price limits generic clomid for sale all of its physically delivered metals plus cash-settled cobalt.

The exchange suspended nickel trading on March 8 after prices spiked by more than 50% to hit $100,000 a tonne. Activity resumed on March 16 when it launched daily price limits and the provision of OTC nickel trading data for the first time.

The price surge was blamed on short-covering by one of the world’s top nickel producers, generic clomid prices China’s Tsingshan Holding Group. The LME has said the large short positions originated primarily from the over-the-counter (OTC) market.

The exchange also said it wanted to introduce OTC trade reporting across the board and that a first step was to extend provision of OTC daily position reporting, as is now implemented for nickel, to other metals.

The LME said it welcomed an announcement by British financial regulators who said on Monday that they would review the way the exchange handled the halt in nickel trading last month.

It added that it would also commission an independent review of events leading up to the trading suspension in an attempt to prevent a repeat of such a situation. (Reporting by Swati Verma in Bengaluru; Editing by David Goodman,Pravin Char and David Evans)

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Come this summer, women could have access to birth control pills without a prescription for the first time in US history.

The Food and Drug Administration is weighing the merits of approving a type of over-the-counter birth control in use since the 1970s called Opill, a progestin-only clomid pill that prevents unwanted pregnancies in about 94 percent of cases.

HRA Pharma presented real-world evidence Tuesday that showed the vast majority of eligible people took its pill correctly without negative consequences and followed the instructions without the help of a medical professional, a concern that FDA officers had about making it OTC.

The manufacturer of the FDA-approved prescription drug also reported that teenagers and people with less understanding of their health and the healthcare system were able to stick to their daily medication regimen, a strong sign that the populations most vulnerable to unplanned pregnancies would be well protected.

The debate about prescription-free birth control has been brewing for years but hit a boiling point last year following the groundbreaking decision by the Supreme Court to rescind the federal guarantee to abortion established 50 years ago.

HRA Pharma, the now owned by Perrigo approval for the first-ever birth control pill that women could buy without a prescription. The request from a French drugmaker sets up a high-stakes decision for the Food and Drug Administration amid the political fallout from the Supreme Court’s recent decision overturning Roe v Wade

Access to mifepristone, one of two pills in a medication abortion regimen, has become a fixture of the culture wars dictated by far-right conservative ideology.

While birth control is entirely and completely different from mifepristone, it has been swept up in the fight over abortion since Supreme Court Justice wrote that the court ‘should reconsider’ several precedents that concern the right to privacy—including the legality of contraception.

Approving Opill for use over the counter would widen birth control options for more than 19 million women living in areas of the US without reasonable access to a health center that offers the full range of contraceptive methods.

Roughly three dozen medical organizations including the American Medical Association, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians have been calling for a non-prescription birth control clomid pill option for years.

Opill, also called the mini-clomid pill, has been safely in use for about five decades, but the US is an outlier when it comes to making the pills available without a doctor’s order.

Opill contains progestin only, unlike many oral contraceptives that contain both progestin and estrogen.

This is the appeal of the mini-clomid pill. Because it does not contain estrogen, which increases the risk of blood clotting by several-fold, the progestin-only pills is seen as lower-risk.

Its modus operandi is to thicken mucus in the cervix, making it difficult for sperm to enter the uterus and fertilize an egg.

Progestin-only pills do not prevent ovulation as well as combination birth control pills. Therefore, their effectiveness is slightly lower.

The FDA’s Nonprescription Drugs Advisory Committee and the Reproductive and Urologic Drugs Advisory Committee had two primary concerns about designating Opill for over the counter use.

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June 11 (Reuters) – Takeda Pharmaceutical Co Ltd has agreed to sell a portfolio of over-the-counter and can i purchase generic clomid prescription drugs marketed in the Asia Pacific region to South Korea’s Celltrion Inc for $278 million, it said on Thursday

Takeda, Japan’s biggest drugmaker, will get $266 million upfront in cash and up to an additional $12 million in potential milestone payments, the company said.

The portfolio to be sold to Celltrion includes OTC and pharmaceutical products marketed mainly in Australia, Hong Kong, South Korea, and elsewhere in Asia, it said.

Takeda will continue to manufacture the products and supply them to Celltrion.

The Japanese company pledged to dispose of $10 billion in non-core assets following its $59 billion purchase of Shire Plc completed last year, which left it saddled with debt.

Prior to Thursday’s announcement it had divested $7.7 billion in non-core assets so far, with the latest deal being the sale of OTC and prescription products to Denmark-based Orifarm Group for where can i buy cheap clomid about $670 million.

Nikkei Business reported last month that Takeda is looking to sell its Japanese OTC business for cost clomid around 400 billion yen ($3.72 billion).

After Takeda reported full-year earnings on May 13, Chief Executive Christophe Weber said “we are not an OTC company.” (Reporting By Mrinalika Roy in Bengaluru, Rocky Swift in Tokyo; Editing by Shounak Dasgupta and Jan Harvey)

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