Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) Single-Dose Vial, a generic therapeutic equivalent version of (RLD), LEVOPHED injection of Hospira Inc.

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients with acute hypotensive states. According to IQVIA (IMS Health), Norepinephrine Bitartrate Injection USP had US sales of approximately $40 million for the 12-month period ending June 2023.

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Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day (USRLD: Ortho Evra Transdermal System, 150 mcg/35 mcg per day).

Norelgestromin and Ethinyl Estradiol Transdermal System contains combination hormone medication and is used to prevent pregnancy. This is the third hormonal transdermal patch to be approved from Zydus’ generics portfolio. The transdermal patch will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad.

Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of $330 million in the US (IQVIA MAT July 2023).

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Strides Pharma Science announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tivicay Tablets of ViiV Healthcare Company. The approval adds to a list of products that Strides has approved under the PEPFAR pathway taking the total to 13 products.

The Dolutegravir 50mg tablet has a market opportunity in the US of $1,345 million per IQVIA. The products will be manufactured at the company’s facility in Bengaluru. The conversion of this tentative approval to a full approval is expected upon expiry of the constraining patents.

The PEPFAR tentative approval for Strides qualifies the Company to participate in global donor funded programs that procure this lifesaving medicine and it is supplied in 126 countries. As of full year 2022, donor procurement for Dolutegravir 50mg tablet is estimated at a value of $35 million. This product further strengthens the available offerings in HIV treatment from Strides.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch 60 new products over three years in the US.

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Akums Drugs and Pharmaceuticals has launched Tamsulosin + Tadalafil Capsule in the Indian market after getting approval from the Drug Controller General of India (DCGI) for the formulation of Tamsulosin 0.4/0.4mg + Tadalafil 2.5/5mg.

Tamsulosin is a selective alpha1A-adrenergic receptor antagonist. The effects of tamsulosin are targeted for the smooth muscle receptors of the prostate and urethra. Blocking this receptor relaxes the smooth muscle of the bladder and urethra to improve urine flow. It is primarily used when an enlarged prostate impedes normal urine flow and bladder emptying.

In tandem, the mechanism of action for Tadalafil centers on the inhibition of PDE5, a crucial enzyme located in the vascular smooth muscle cells of corpus cavernosum. By impeding cGMP hydrolysis, Tadalafil promotes cGMP accumulation and the relaxation of vascular smooth muscle, facilitating the development of a physiologically-induced erection, contingent upon sexual stimulation.

Sanjeev Jain, Jt MD, Akums Drugs & Pharmaceuticals said, “This innovative combination therapy not only offers a more convenient treatment option but also represents a significant leap forward in our pursuit of enhancing patient outcomes.”

Sandeep Jain, Jt MD, Akums Drugs & Pharmaceuticals added, “The Tamsulosin + Tadalafil Capsule stands as a testament to Akums’ dedication to innovation and our commitment to elevating healthcare standards.”

Each hard gelatin capsule is composed of Tamsulosin Hydrochloride IP at 0.4/0.4mg (in its extended-release form) and Tadalafil IP at 2.5/5mg (as a film coated tablet).

A company statement informs that the Tamsulosin + Tadalafil Capsule demonstrates significant improvements in BPH and Erectile Dysfunction Index, the combination significantly improves Total, Voiding, and Storage International Prostate Symptom Score (IPSS), thereby offering a better efficacy on LUTS relief.

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UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an adapted Pfizer/BioNTech COVID-19 vaccine that targets the Omicron XBB 1.5 subvariant, after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.

The vaccine has been approved for use in individuals from six months of age.

The adapted vaccine works in the same way as the original vaccine by causing the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19.

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Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg (RLD: Accutane Capsules, 10 mg, 20 mg and 40 mg: RS: Claravis 10 mg, 20 mg, 30 mg and 40 mg).

Isotretinoin Capsules is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (such as benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).

Section 505-1 of the FD&C Act authorizes FDA to require the submission of a Risk Evaluation and Mitigation Strategy (REMS) for this product. Zydus’ proposed REMS has also been approved by FDA. The Isotretinoin iPLEDGE REMS consists of Elements to Assure Safe Use (ETASU) and an implementation system.

Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg had annual sales of $165 million in the United States (IQVIA MAT July 2023). The group now has 378 approvals and has so far filed over 444 ANDAs since the commencement of the filing process in FY 2003-04.

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Ajanta Pharma has received final approval from the United States Food and Drug Administration (USFDA) to market Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg and 200 mg.

Topiramate is the generic version of Supernus Pharmaceuticals Inc’s Trokendi XR. As per the settlement with the innovator, Ajanta can launch Topiramate on February 1, 2026 or earlier under certain circumstances.

Ajanta has received 50 final ANDA approvals, out of which 41 are commercialized. Ajanta also holds two tentative approvals and 22 ANDAs are awaiting US FDA approvals.

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Strides Pharma Science announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), CellCept for Oral Suspension, 200 mg/mL of Roche Palo Alto. The approval bolsters the company’s Mycophenolate Mofetil portfolio.

The Mycophenolate Mofetil for Oral Suspension has a market size of $41 million per IQVIA. The entire Mycophenolate Mofetil range of products for the company has a cumulative market opportunity of $145 million per IQVIA. The products will be manufactured at the company’s facility in Bengaluru.

The company has 280 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 260+ ANDAs have been approved. The company has set a target to launch 60 new products over three years in the US.

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Venus Remedies has received marketing approval from Saudi Arabia for its product Enoxaparin in pre-filled syringes.

A company statement informed that Venus Remedies has an annual capacity of producing more than five million units of Enoxaparin, a widely used anticoagulant that prevents blood clots, at its robotic line. Having secured marketing authorisations from Saudi Arabia for six antibiotics meant for intensive care units and three oncology products, Venus Remedies has so far sold more than 12 million units of drugs in the $7.8-billion Saudi Arabian pharma market (as in 2021), which is expected to grow to $13.1 billion by 2031 at a 10-year CAGR of 5.4 per cent.

The marketing approval for Enoxaparin from Saudi Arabia is expected to soon pave the way for grant of marketing authorisations to Venus Remedies for the drug from other countries in GCC and Middle East and North Africa (MENA) regions where the submissions have already been made and consider the Saudi Food and Drug Authority (SFDA) as a reference authority.

Enoxaparin plays a role in addressing blood clot formation in patients suffering from deep-vein thrombosis, acute coronary syndrome, heart attacks and pulmonary embolism.

Reportedly, Venus is awaiting marketing approval from Saudi Arabia for another six-seven oncology drugs anytime soon.

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This product will be manufactured at Lupin’s Pithampur facility in India

Lupin has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for Pirfenidone Tablets, 267 mg and 801 mg, to market a generic equivalent of Esbriet Tablets, 267 mg and 801 mg of Hoffmann La Roche Inc.

This product will be manufactured at Lupin’s Pithampur facility in India.

Pirfenidone Tablets (RLD Esbriet) had estimated annual sales of USD 218 million in the U.S. (IQVIA MAT June 2023).

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