Mylan Laboratories Gets CDSCO Nod to Manufacture and Market Epinephrine tartrate Injection

New Delhi: Mylan Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Epinephrine tartrate Injection IP 0.3mg/0.3ml & 0.15mg/0.3ml (Auto injector) (Adrenaline Injection IP).

This came after the firm presented their proposal for a grant of permission to manufacture and market Epinephrine tartrate Injection IP 0.3mg/0.3ml and 0.15mg/0.3ml (Auto-injector) along with justification for bioequivalence (BE) waiver and clinical trial waiver.

Epinephrine is a hormone and neurotransmitter used to treat allergic reactions, to restore cardiac rhythm, and to control mucosal congestion, glaucoma, and asthma.Epinephrine injection is indicated in the emergency treatment of type I allergic reactions, including anaphylaxis. It is also used to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

The firm has informed that Epinephrine tartrate Injection IP 0.3mg/0.3ml & 0.15mg/0.3ml (Auto injector) is already approved in USA.

At the recent SEC meeting for pulmonary held on 3rd October 2024, the expert panel reviewed the proposal for the grant of permission to manufacture and marketing of Epinephrine tartrate Injection IP 0.3mg/0.3ml & 0.15mg/0.3ml (Auto injector) along with justification for BE waiver and clinical trial waiver.

After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of Epinephrine tartrate Injection IP 0.3mg/0.3ml & 0.15mg/0.3ml (Auto-injector) with different color coding for each applied strength.

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