Posts in category: News

Main Products, Inc. is voluntarily recalling all lots of “Umary Acido Hialuronico, Suplemento Alimenticio – 30 Capletas de 850mg” to the consumer level. FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole. Products containing diclofenac and omeprazole cannot be marketed as dietary supplements. UMARY is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). There is a reasonable probability that consumption of high levels of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses.

Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acidrelated disorders. PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea, and headache. This hidden ingredient may mask stomach issues such as erosions, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications. The product is used as a dietary supplement promoted and sold for pain and is packaged in bottles with 30 caplets. The affected product includes all lots within expiry. The product was distributed via online store Main Products, Inc. on Amazon.com.

Main Products, Inc. is notifying its customers by email and is arranging for the return of all recalled products. Consumers that have UMARY which is being recalled should stop using and return to their place of purchase. Consumers may return the products to the address below.

Main Products, Inc., 1551 Glenwood Springs Ave., Chula Vista CA, 91913
www.main-products.com.
Source: FDA

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Endo, Inc announced that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg tablets 60-count pack to the consumer level.

The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125mg and not 0.25mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25mg.

This recall impacts the following product lot:

• See below image of correct carton label: Clonazepam Orally Disintegrating Tablets, USP 0.25mg 60-count carton, lot 550147301, expiration date August 2026
• See below image of incorrect carton label: Clonazepam Orally Disintegrating Tablets, USP 0.125mg
  60-count carton, lot 550147301, expiration date August 2026

(Note: No BeneCard PBF members were affected by this recall.)
Source: FDA

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FDA Approves Femlyv Orally Disintegrating Birth Control Pill

The U.S. Food and Drug Administration (FDA) approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy.

• Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved
  in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
• Femlyv is the first FDA-approved dissolvable birth control pill, designed for individuals who have
  trouble swallowing their medication.
  Source: FDA

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FDA Approves Vigafyde™ as the First and Only Ready-to-Use Vigabatrin Oral Solution

Pyros Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Vigafyde™, the only ready-to-use vigabatrin oral solution, as a monotherapy for the treatment of pediatric patients 1 month to 2 years of age with infantile spasms (IS), where the potential benefits outweigh the potential risk of vision loss.

• Infantile spasms, a rare but severe form of epilepsy, pose significant challenges for patients and their families.
• Pyros provides ongoing personalized support to caregivers. The support program offers personal assistance and financial resources to caregivers whose child is starting or continuing therapy.
• Vigafyde™ is expected to be available in the second half of 2024.

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FDA Approves Pyzchiva, a Biosimilar to Stelara

Sandoz has announced that the U.S. Food and Drug Administration (FDA) approved biosimilar Pyzchiva®* (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130mg/26mL (5mg/mL) single-dose vial for intravenous infusion. Developed by Samsung Bioepis Co., Ltd, it is approved for all indications of its reference medicine and will be commercialized by Sandoz in the US.

• Pyzchiva® is approved by the FDA for all indications of the reference medicine
  Stelara®† (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist including to treat adult
  patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis, as well as pediatric patients with moderate to severe plaque psoriasis and active psoriatic arthritis.
• In addition, the FDA provisionally determined that Pyzchiva® would be interchangeable with the
  reference medicine as it is currently subject to an unexpired period of exclusivity for the first
  interchangeable biosimilar biological products.
• Sandoz intends to launch Pyzchiva® in the US in February 2025.
• *Pyzchiva® is a trademark of Samsung Bioepis Co. Ltd.† Stelara® is a registered trademark of JOHNSON & JOHNSON (USA).

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FDA Approves Nypozi, a Biosimilar to Neupogen

– Tanvex BioPharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved the biologics license application (BLA) of Nypozi.

• Nypozi, proposed biosimilar to the reference product Amgen’s NEUPOGEN® – is indicated to
  decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant
  incidence of severe neutropenia with fever.
• Tanvex’s Nypozi has been launched in Canada in January 2024.

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American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21
batches of Potassium Chloride Extended-Release Capsules, USP (750mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.

Potassium Chloride Extended-Release Capsules are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68001-396-00) and 500-count (NDC 68001-396-03) capsules

Consumers that have Potassium Chloride Extended-Release Capsules subject to the recall should consult
with their physician or health care provider before they stop using the product. Consumers should also
contact their physician or healthcare provider if they have experienced any problems that may be related
to taking or using this drug product. Consumers should call Sedgwick, a recall solution vendor, at 1-855-
695-8564, Monday – Friday, 8:00 am – 5:00 pm EST for return instructions and further information. (Note: One Benecard Central Fill member was affected by this recall and member outreach was completed.)\

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FDA Approves PiaSky for the Treatment of Paroxysmal Nocturnal Hemoglobinuria

The U.S. Food and Drug Administration (FDA) approved PiaSky (crovalimab-akkz) for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.

• Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood condition in which
  red blood cells are destroyed by the body’s complement system (part of the innate immune
  system). This causes symptoms such as anemia, fatigue, and blood clots, and can lead to kidney
  disease.
• PiaSky contains crovalimab-akkz which is a C5 inhibitor that is recycled within the bloodstream,
  enabling sustained complement inhibition through low-dose administration every four weeks.
• PiaSky is administered as a single loading dose by intravenous infusion on Day 1, followed by four
  additional weekly loading doses administered by subcutaneous injection on Days 2, 8, 15, and 22.
  Maintenance dosing starts on Day 29 and is administered every 4 weeks by subcutaneous injection.

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Clinical dermatology company, Botanix Pharmaceuticals Ltd. announced the U.S. Food and Drug Administration (FDA) has approved Sofdra™ (sofpironium) gel, 12.45%, a prescription medicine used to treat primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years and
older.

• Hyperhidrosis is a condition characterized by abnormally increased sweating, beyond that required
  to regulate body temperature. The disproportionate sweat production that characterizes
  hyperhidrosis, results in a disabling medical condition with profound effects on the patient’s quality
  of life.
• Sofdra is the first and only new chemical entity approved by the FDA to treat primary axillary
  hyperhidrosis and presents a novel safe and effective solution for patients who have lacked
  treatment options for this socially challenging medical condition.
• Hyperhidrosis is the third largest dermatology condition (after acne and atopic dermatitis), with
  approximately 10 million patients in the US with primary axillary hyperhidrosis.

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