MYLOTARG (gemtuzumab ozogamicin) for injection
MYLOTARG is a CD33-directed antibody-drug conjugate used to treat patients with acute myeloid leukemia (AML).
| Brand Name: | MYLOTARG |
| Generic Name: | Gemtuzumab ozogamicin Injection |
| Strength: | • For Injection: 4.5 mg as a lyophilized cake or powder in a single-dose vial for reconstitution and dilution |
| Manufacturer: | Pfizer Inc |
| Approved By: | EMA, USFDA |
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Contact Person: Jitender Mishra
Company: Lucknow Speciality Pharma
Address: 2nd Floor, 207-A, Felix Square, Golf City, Gomti Nagar, Lucknow, Uttar Pradesh 226030
Phone: 9336559090, 9760014849
WhatsApp: 9336559090, 9760014849
Email: info@lucknowpharma.com
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What is the use of gemtuzumab ozogamicin for injection?
Gemtuzumab ozogamicin is an antibody-drug conjugate that is recommended in the treatment of Haematological disorders. It is specifically indicated in the management of AML - acute myeloid leukemia. Mylotarg is the brand or trade name of this drug which is now commercially promoted by Pfizer. It was originally developed by Celltech and Wyeth, a collaboration that also developed other significant drugs. Mylotarg is used both in adult and paediatric patients. Gemtuzumab in India has to be imported for specific patient usage purpose
Mylotarg in India is a treatment option recommended by Haematologists who also have BMT expertise. In several cases, BMT is the ultimate treatment modality recommended and drugs like Gemtuzumab are given prior to it. As per the initial FDA approval in 2000, it was approved for the patients over sixty years. It was specific in relapsed AML. It was also approved for the usage in patients that are not fit or eligible for the standard chemotherapy. This was an accelerated approval. This drug was commercially withdrawn in 2010, due the data pointing towards increasing VOD risk in the patients on therapy. However, it was reapproved in 2017 both by the US FDA and EMA.
Gemtuzumab ozogamicin is a monoclonal antibody which is an advanced type of targeted therapy agent. It is prescribed both as a single agent as well as in combination with other chemotherapy agents. Mylotarg 4.5mg vials are commercially available in the US and Europe. Import channels are possible for Indian patients.
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What is the role of Lucknow Speciality Pharma?
- Processing regulatory documentation and CDSCO import permit filings (Form 12A/12B).
- Coordinating customs clearance and end-to-end import formalities.
- Managing GDP-compliant, temperature-controlled cold-chain logistics for direct delivery to hospitals or individual patients.
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Key Metropolitan & Regional Delivery Hubs:
- Delhi (NCR): Delhi, Gurugram, Noida, Greater Noida, Ghaziabad.
- Uttar Pradesh: Lucknow, Kanpur, Prayagraj, Varanasi, Agra, Meerut, Bareilly, Gorakhpur, Aligarh, Moradabad, Jhansi, Mathura–Vrindavan, Ayodhya, and surrounding districts.
- Eastern & Central India: Patna, Gaya, Bhagalpur, Muzaffarpur, Darbhanga (Bihar); Ranchi (Jharkhand); Bhopal, Indore (Madhya Pradesh); Raipur (Chhattisgarh); Jaipur (Rajasthan); Dehradun (Uttarakhand).
- Expanded Regional Coverage: Guwahati (Assam), Agartala (Tripura), Imphal (Manipur), Kolkata, Siliguri, Asansol (West Bengal), and Nepal.
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