Alembic Pharma USFDA approvals 2026: Lamotrigine, Bosutinib

A steady run of regulatory updates

Alembic Pharmaceuticals has reported a series of US Food and Drug Administration (USFDA) decisions across its US generics portfolio, spanning neurology, oncology, and cardiovascular therapies. The company said it received USFDA approval for generic Lamotrigine tablets used to treat seizures. The ANDA is stated to be therapeutically equivalent to GlaxoSmithKline’s Lamictal.

Alongside the Lamotrigine update, Alembic also disclosed a tentative approval for Bosutinib tablets, 400 mg, through a supplemental abbreviated new drug application (sANDA). In a separate announcement, it said the USFDA granted final approval for Macitentan tablets, 10 mg, used in pulmonary arterial hypertension (PAH).

Lamotrigine approval: seizure treatment focus

Lamotrigine is used in the treatment of seizures, and the update adds another product to Alembic’s US-facing filings and approvals. The company’s note specifies that Alembic’s Lamotrigine tablets are tied to an ANDA that is therapeutically equivalent to the reference brand Lamictal from GlaxoSmithKline.

While the disclosure does not include dosage strengths or launch timelines, the approval highlights Alembic’s ongoing activity in complex and chronic therapy categories where continuity of supply and pricing can matter to both payers and patients.

Bosutinib 400 mg gets tentative USFDA approval

Alembic said it has secured tentative USFDA approval for Bosutinib tablets, 400 mg. The tentative approval is for a supplemental abbreviated new drug application (sANDA), as disclosed in a regulatory filing.

The company added that the approved ANDA is therapeutically equivalent to the reference listed drug (RLD) product Bosulif tablets, 400 mg, of PF Prism CV. Alembic also noted it already has final USFDA approvals for Bosutinib tablets in 100 mg and 500 mg strengths.

Alembic described the 400 mg strength as an additional opportunity in the molecule’s lifecycle, indicating that the new strength expands the addressable set of prescriptions within the same product family.

Macitentan 10 mg receives final approval

In another development, Alembic Pharmaceuticals said the USFDA granted final approval to its ANDA for Macitentan tablets, 10 mg. The company stated the product is therapeutically equivalent to Opsumit tablets, 10 mg, from Actelion Pharmaceuticals US, Inc.

Macitentan is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults. Alembic’s note said the therapy helps reduce the risk of disease progression and lowers hospitalization in PAH patients.

PAH pipeline link: Selexipag injection mentioned

Alembic also referenced a prior tentative USFDA approval, granted in July, for Selexipag for Injection, 1,800 mcg/vial. The company described Selexipag as another PAH therapy that helps slow progression and reduce hospital visits.

Taken together with Macitentan’s final approval, these updates underline the company’s stated intent to build out its cardiovascular and PAH-focused offerings in the regulated market.

ANDA approval count: 224, with varying splits cited

Alembic said it now has 224 ANDA approvals from the USFDA. In one disclosure, the company stated that out of 224, 203 were final and 21 were tentative.

In a separate June 2025 update tied to an oncology approval, Alembic again cited 224 total ANDA approvals, but described the mix as 201 final approvals and 23 tentative approvals. The common point across the disclosures is the overall total of 224, even as the final versus tentative split is presented differently in different updates.

Oncology approval and stock reaction: Doxorubicin Liposome Injection

Alembic said it received final USFDA approval for its generic Doxorubicin Hydrochloride Liposome Injection. The product is approved in 20 mg/10 mL and 50 mg/25 mL single-dose vials, and is used to treat conditions including ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma.

The company described the drug as a generic equivalent of Doxil, originally marketed by Baxter Healthcare. In one market update, Alembic shares were reported to have rallied over 8% in early trading after the announcement. At 9:40 a.m. IST, the stock was quoted at ₹1,055.80 on the NSE, up ₹85.90 or 8.97% from the previous close of ₹968.90.

IQVIA data cited in the update pegged the market size for this formulation at approximately US$19 million for the twelve months ending March 2025.

Another CNS product: Carbamazepine tablets approval and market size

Separately, Alembic received USFDA approval for Carbamazepine tablets USP, 200 mg, described as a generic anticonvulsant. The product is therapeutically equivalent to the reference listed drug Tegretol tablets, 200 mg, of Novartis Pharmaceutical Corporation.

The filing noted the product is indicated as an anticonvulsant and is also used for pain associated with trigeminal neuralgia. IQVIA data cited in that report estimated the market size at US$12 million for the 12 months ending December 2024. The same report noted Alembic shares were trading at ₹849.85 on the BSE, down 0.21%.

Other US approval and a US acquisition in the background

Alembic has also received final USFDA approval for Pantoprazole Sodium for Injection, 40 mg/vial, in a single-dose form. Beyond approvals, Alembic Pharmaceuticals Inc., a wholly owned subsidiary, acquired a 100% stake in Utility Therapeutics Ltd, a company focused on urinary tract infection (UTI) treatments.

Utility Therapeutics is developing and seeking approvals for two brand products, per the disclosure. “Pivya” is described as an FDA-approved product for uncomplicated UTIs in the US market, while “MEC” is stated to be in development for complicated UTIs.

Key product approvals and references at a glance

Market impact and why these updates matter

The sequence of approvals and tentative decisions points to continued execution in Alembic’s regulated-market pipeline, with products spanning neurology (Lamotrigine, Carbamazepine), oncology (Bosutinib, Doxorubicin), and cardiovascular or PAH therapy (Macitentan, Selexipag). The most immediate market-linked datapoints in the disclosures came from the Doxorubicin approval, where the stock was reported up 8.97% to ₹1,055.80 in early trade, and from the Carbamazepine approval report, where the stock was noted at ₹849.85, down 0.21%.

The market-size figures cited, approximately US$19 million (Doxorubicin formulation) and US$12 million (Carbamazepine 200 mg), provide context on the scale of opportunity, although actual revenue outcomes depend on factors not included in the disclosures, such as launch timing, competition, and pricing.

Conclusion

Alembic’s recent USFDA updates cover a broad range of generics and dosage forms, including Lamotrigine for seizures, tentative clearance for Bosutinib 400 mg, and final approval for Macitentan 10 mg. The company has also pointed to a wider pipeline, including a prior tentative decision for Selexipag injection and a final approval for Doxorubicin Hydrochloride Liposome Injection.

Next milestones to watch, based on what the company has already disclosed, are any further updates on converting tentative approvals into final approvals and any announcements on launch plans for products that have received final clearances.