Doxorubicin Hydrochloride Liposome - newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu & Kashmir, Trending news | News Mantra https://newsmantra.in/tag/doxorubicin-hydrochloride-liposome/ Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu & Kashmir, Trending news | News Mantra Mon, 30 Jun 2025 11:33:09 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.3 https://newsmantra.in/wp-content/uploads/2019/05/cropped-newmantra-logo-32x32.png Doxorubicin Hydrochloride Liposome - newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu & Kashmir, Trending news | News Mantra https://newsmantra.in/tag/doxorubicin-hydrochloride-liposome/ 32 32 Alembic Pharmaceuticals Limited announces USFDA Final Approval for Doxorubicin Hydrochloride Liposome Injection https://newsmantra.in/alembic-pharmaceuticals-limited-announces-usfda-final-approval-for-doxorubicin-hydrochloride-liposome-injection/ Mon, 30 Jun 2025 11:33:09 +0000 https://newsmantra.in/?p=64908 30th June, 2025 Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. The approved ANDA...

The post Alembic Pharmaceuticals Limited announces USFDA Final Approval for Doxorubicin Hydrochloride Liposome Injection appeared first on newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu & Kashmir, Trending news | News Mantra.

]]> 30th June, 2025 Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation.

Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi’s Sarcoma, and Multiple Myeloma. Refer label for a detailed indication.

Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2mg/mL) Single-Dose Vials have an estimated market size of US$ 29 million for twelve months ending March 2025 according to IQVIA.

Alembic has a cumulative total of 224 ANDA approvals (201 final approvals and 23 tentative approvals) from USFDA.

The post Alembic Pharmaceuticals Limited announces USFDA Final Approval for Doxorubicin Hydrochloride Liposome Injection appeared first on newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu & Kashmir, Trending news | News Mantra.

]]>