The USFDA Gives Final Approval to Zydus for their 0.75% Metronidazole Topical Cream

The US Food and Drug Administration has given final approval to Zydus Lifesciences Limited (together with its subsidiaries and affiliates, hereafter referred to as “Zydus”) to produce and distribute Metronidazole Topical Cream, 0.75% (USRLD: MetroCream, 0.75%). An antibiotic called metronidazole is applied to the skin to treat rosacea, a form of adult acne. It is anticipated to aid in reducing redness, swelling, and the quantity of pimples brought on by rosacea and is thought to function by reducing swelling (inflammation).

The group’s topical manufacturing facility in Changodar, Ahmedabad (India), will produce the medication. In the United States, metronidazole topical cream, 0.75% had annual sales of USD 25 million (IQVIA MAT Feb. 2023). Since the filing procedure began in FY 2003–2004, the group has received 366 approvals and has submitted over 440* ANDAs to date.

More About Zydus

Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India. The company was founded in 1952 and has since become one of the leading healthcare companies in India, with a presence in over 50 countries worldwide. Zydus Cadila operates in multiple segments, including human formulations, active pharmaceutical ingredients (APIs), biosimilars, animal health products, and wellness products. The company has a strong research and development (R&D) pipeline and invests heavily in innovation and technology to develop new and effective drugs.

Zydus Cadila has a diverse portfolio of products covering a range of therapeutic areas, including cardiovascular, respiratory, oncology, gastroenterology, and pain management. The company has received multiple certifications and awards for its high-quality products and services. In addition to its pharmaceutical business, Zydus Cadila has a strong commitment to corporate social responsibility and is involved in various initiatives aimed at improving healthcare, education, and the environment.

More About Metronidazole Topical Cream, 0.75%

Metronidazole Topical Cream, 0.75% is a prescription medication used to treat the skin condition rosacea. Rosacea is a chronic inflammatory condition that causes redness, flushing, and small, pus-filled bumps on the face, particularly in the nose and cheeks. Metronidazole is an antibiotic that has anti-inflammatory properties, making it effective in treating rosacea. When applied topically, it helps to reduce the inflammation and redness associated with the condition.

Metronidazole Topical Cream, 0.75% is typically applied to the affected area twice daily for a period of several weeks or months, depending on the severity of the condition. It is important to follow the dosage and application instructions provided by a healthcare professional to ensure effective and safe use of the medication. As with any medication, Metronidazole Topical Cream, 0.75% may cause side effects, such as skin irritation, itching, or dryness. If you experience any unusual symptoms while using this medication, it is important to consult with a healthcare professional.

More About USFDA

The US Food and Drug Administration (FDA) is a regulatory agency of the United States Department of Health and Human Services responsible for protecting and promoting public health through the regulation of various products, including food, drugs, medical devices, and cosmetics.

The FDA’s main responsibilities include:

  1. Ensuring the safety, efficacy, and quality of food, drugs, medical devices, and cosmetics sold in the United States.
  2. Conducting pre-market review and approval of drugs, biologics, and medical devices.
  3. Regulating the labeling and advertising of products to ensure that they are truthful and not misleading.
  4. Monitoring the safety of products after they are on the market and taking appropriate action when safety concerns arise.
  5. Providing guidance to industry on regulatory requirements and processes.

The FDA is known for its rigorous standards and extensive review processes, which are designed to protect the public from unsafe or ineffective products. The agency also works closely with other government agencies, international organizations, and the private sector to promote global public health and advance scientific research.

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