Paxlovid and Dong-A’s Diosmin Powder were approved in July

MFDS approved 29 ETCs and 47 OTCs in July

Celltrion’s antidiabetic combo from Takeda approved for exports

KyungDong Pharma increases dosage form for its Gnal-N and creates a soft-capsule lineup

The number of prescription drug approvals decreased significantly in July.

 

The approvals, which had continuously increased from 70 in May to 93 in June, had fallen to record 29 in July.

 

However, the drugs approved were nevertheless as significant as Pfizer Korea’s COVID-19 treatment ‘Paxlovid (nirmatrelvir, ritonavir)’, which had first been introduced to Korea through the EUA (emergency use authorization) during the COVID-19 outbreak, received formal approval as a new drug in Korea, and the Takeda-developed Celltrion-owned ‘Alo Gliptinpio Tab’ was approved for export.

 

Drugs Approved in 2023

In July, a total of 76 drugs were approved by the Ministry of Food and Drug Safety.

 

Compared to the previous month, the ETC approvals were reduced by 64, and OTC approvals increased to 47 and exceeded the number of ETC approvals.

 

◆OTC drugs== A total of 47 over-the-counter drugs were approved (registered) in July.

 

Among those, 3 were data submission drugs(incrementally modified drugs, IMDs), which are modified versions of existing drugs that underwent safety and efficacy reviews due to changes in ingredient, salt base, or dosage form.

 

OTCs approved in July

KyungDong Pharma’s Gnal-N Ace Soft Cap (IMD, approved on July 12) Gnal-N is the first product that made KyungDong Pharm, a pharmaceutical company that had previously been focused on clinical areas, familiar to the public.

 

The Gnal-N series was first released in 2009 with the ibuprofen combo ‘Gnal-N Tab,’ followed by ‘Gnal-N Q Tab', ‘Gnal-N Nose Soft Cap, ‘Gnal-N Cold Soft Cap,’ ‘Gnal-N Cough Soft Cap,’ ‘Gnal-N Nose Plus Soft Cap.’ The company received additional approval for ‘Gnal-N Ace Soft Cap’ which contains a combination of acetaminophen and riboflavin on July 12, and increased its Gnal-N product line-up to 13.

 

Gnal-N Ace Soft Cap is indicated for headache, toothache, pain after tooth extraction, sore throat, ear pain, joint pain, neuralgia, back pain, muscle pain, shoulder pain (stiff shoulder), bruise pain, fracture pain, sprain pain, menstrual pain.

 

analgesia of traumatic pain, chills, and fever.

 

Dong-A Pharmaceutical’s Dong-A Pharm Diosmin Suspension Powder (IMD, approved on July 18) Dong-A Pharmaceutical will soon be releasing its approved ‘Dong-A Pharm Diosmin Suspension Powder’ that offers improved convenience in intake to pharmacies in Korea.

 

Each packet of the drug contains diosmin 600mg that can be dissolved into water for intake.

 

It is indicated to improve symptoms related to venous insufficiency (leg heaviness, pain), as supplementary treatment for disorders caused by capillary fragility, and treatment of symptoms related to hemorrhoids.

 

It will be released to pharmacies as a box with 10 packets.

 

Meanwhile, latecomers such as Dong-A Pharmaceutical, Hanmi Pharm, Chodang Pharm, and Samjin Pharm have increased their presence in the diosmin market by releasing high-dose oral hemorrhoids treatments one after another.

 

Dong-A Pharmaceutical's annual sales of Diomax Tab doubled from KRW 500 million in 2020 to KRW 1 billion in 2021, based on IQVIA data.

 

Last year, Diomax posted sales of KRW 1.1 billion, occupying 48% of the market the high-dose (600mg) oral hemorrhoids treatment market.

 

ETCs approved in July

◆ETC=Two new prescription drugs were approved in July.

 

14 data submission drugs and 13 generics and others were also approved the same month.

 

Celltrion’s ‘Celltrion Alo Gliptinpio Tab 25·15mg, 25·30mg (for export, Approved on July 6 and 7) Celltrion received approval for Celltrion Alo Gliptinpio Tab 25·15mg, and 25·30mg for export on July 6 and 7, respectively.

 

The drug is a new combination made by the company using its rights for ‘Nesina' and 'Actos', which it acquired from the Japanese pharmaceutical company Takeda Pharmaceuticals.

 

Takeda Pharmaceuticals had been directly selling Nesina in Korea until 2020, but in December 2020, it sold all rights, including sales rights and patents, of 12 ETC drug brands and 6 OTC drugs in 9 Asia-Pacific countries to Celltrion Pharm to adjust the size of its debt.

 

I did.

 

Alogliptin and pioglitazone can help patients control blood sugar levels, and patients with Type 2 diabetes can take them to control blood sugar along with diet and exercise.

 

Since last year, Celltrion Pharm has been strengthening its product lineup receiving approval for drugs to export overseas.

 

Sanofi-Aventis Korea’s Enjaymo Inj (new drug, Approved on July 12) Sanofi’s ‘Enjaymo Inj,’ which is indicated to treat adults with cold agglutinin disease (CAD), was also recently approved in Korea.

 

The drug is used to treat the breakdown of red blood cells (hemolysis) in adults with cold agglutinin disease (CAD), which is a form of autoimmune hemolytic anemia (AIHA), CAD is a rare type of autoimmune hemolytic anemia caused when antibodies called cold agglutinins bind to the surface of red blood cells.

 

When cold agglutinins bind to the surface of red blood cells, the body's immune system mistakenly attacks and destroys healthy red blood cells.

 

Pfizer Korea’s Paxlovid Tab (new drug, Approved on July 14) Pfizer Korea’s ‘Paxlovid,’ which was first introduced in Korea through the emergency use authorization (EAU) track during the spread of COVID-19, received official approval in Korea.

 

Paxlovid was granted EAU by the MFDS on December 27, 2021, the same year the number of confirmed and seriously ill patients with COVID-19 surged and the Omicron variant spread, raising the need for an oral treatment for COVID-19.

 

It has been formally approved as a prescription drug 1 year and 7 months after its introduction to Korea.

 

Patients who take Paxlovid take two tablets at the same time.

 

Nirmatrelvir blocks protease (3CL protease) to prevent the production of proteins necessary for viral replication, thereby inhibiting the proliferation of the virus, and ritonavir inhibits the enzyme (CYP3A4) that breaks down nirmatrelvir, extending its duration of effect.

 

After a careful review of the results of the Phase III clinical trial (therapeutic confirmatory trial) conducted on adult patients, the drug was officially approved in Korea in accordance with the 'Pharmaceutical Affairs Act,’ The EAU for Paxlovid, which has allowed patients to use the drug free of charge, will remain in place as is.